JPA
Sysmex Automated Blood Coagulation Analyzer CS-5100
- Advisory panel
- Hematology
- Total cleared
- 180
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JPA
1–100 of 180- K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
- K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
- K232018 — Citrated: K, KH, RTH, FFH
- K233790 — ACL TOP 970 CL
- K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
- K212183 — STA R Max 3, STA Compact Max 3
- K201440 — ROTEM sigma Thromboelastometry System
- K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
- K193041 — Hemochron Signature Elite
- K183390 — QNext and DG-PT
- K183160 — TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
- K173202 — CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
- K172286 — Automated Blood Coagulation Analyzer CS-2500
- K172333 — Sysmex CS-5100
- K160502 — TEG 6s Hemostasis System
- K170314 — ACL AcuStar
- K162688 — Sysmex CS-2100i
- K162420 — Sysmex Automated Blood Coagulation Analyzer CS-5100
- K161317 — Sysmex Automated Blood Coagulation Analyzer CS-5100
- K161312 — Sysmex Automated Blood Coagulation Analyzer CS-2100i
- K151259 — Sysmex Automated Blood Coagulation Analyzer CS-2100i
- K150678 — Sysmex Automated Blood Coagulation Analyzer CS-5100
- K151867 — STA R MAX
- K150041 — CORA (Coagulation Resonance Analysis) System
- K130090 — STA COMPACT MAX
- K101533 — EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
- K083842 — ROTEM DELTA THROMBOELASTOMETRY SYSTEM
- K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
- K093001 — STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
- K083896 — DESTINY MAX COAGULATION ANALYZER
- K083518 — ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
- K083159 — BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
- K083175 — BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
- K082248 — STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
- K082675 — STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
- K071265 — SMARTCHECK INR SYSTEM
- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
- K060162 — ACL ELITE; ACL ELITE PRO
- K051030 — COAG-A-MATE MTX III
- K050053 — HEMORAM/AGGRAM ANALYZER
- K050243 — IMMEDIA PROTHROMBIN TIME SYSTEM
- K050513 — MDA B.30
- K050016 — HEMOCHRON SIGNATURE ELITE
- K040359 — HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
- K033137 — POTENS +
- K030818 — HEMOCHRON RESPONSE/SYSTEM
- K023141 — MODIFICATION TO STANDARD HUMAN PLASMA
- K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
- K020798 — HEMOCHRON JR. SIGNATURE +
- K013114 — BCS SYSTEM
- K011665 — BCT SYSTEM
- K011235 — SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
- K010494 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K002080 — BEHRING COAGULATION SYSTEM, MODEL BCS
- K002177 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
- K994349 — COAGUCHEK S SYSTEM, MODEL 2138280
- K002400 — MODIFICATION OF ACL ADVANCE
- K001064 — BEHRING COAGULATION TIMER ANALYZER (BCT)
- K001067 — DADE BEHRING COAGULATION ANALYZER (BCT)
- K000973 — BEHRING COAGULATION SYSTEM (BCS)
- K993678 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
- K000053 — ACL 9000 SYSTEM
- K992959 — BEHRING COAGULATION SYSTEM (BCS)
- K984501 — DADE BEHRING BFTII
- K990566 — TAS ANALYZER, MODEL 1009
- K983892 — COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
- K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
- K983460 — STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
- K980839 — AVOCET PT
- K981711 — SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
- K981815 — HEPTRAC ELECTRONIC QUALITY CONTROL
- K974799 — HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
- K974569 — COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
- K972260 — CS-400 COAGULATION ANALYZER SYSTEM (A1208)
- K970431 — BEHRING COAGULATION SYSTEM
- K964946 — SYSMEX CA-1000/SYSMEX CA-5000
- K961908 — THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
- K960875 — KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
- K954202 — PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
- K955720 — AMAX CS-190 COAGULATION ANALYZER SYSTEM
- K955724 — KC 1A COAGULATION ANALYZER/SET
- K955735 — KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
- K952625 — COAGUCHEK SYSTEM
- K951891 — ACL FUTURA COAGULATION SYSTEM
- K952560 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER
- K951497 — CASCASE 480 SNSLYZER
- K926551 — BEHRING FIBRINTIMER A
- K942096 — TOA MEDICAL ELECTRONICS CA-1000
- K942097 — TOA MEDICAL ELECTRONICS CA-5000
- K940957 — HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
- K940840 — ACT CONTROL SET
- K940401 — JR. MICROCOAGULATION SYSTEM
- K933886 — TOA MEDICAL ELECTRONICS CA-5000
- K934747 — R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
- K931149 — CA-1000 AUTOMATED COAGULATION ANALYZER
- K933188 — DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
- K930068 — HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION
- K930454 — BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
- K930849 — VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
Data sourced from openFDA. This site is unofficial and independent of the FDA.