Instrumentation Laboratory CO
FDA 510(k) medical device clearances.
Top product codes for Instrumentation Laboratory CO
Recent clearances by Instrumentation Laboratory CO
1–100 of 321- K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
- K223187 — HemosIL Liquid Anti-Xa
- K223090 — GEM Premier ChemSTAT
- K223402 — HemosIL von Willebrand Factor Antigen
- K213464 — HemosIL Liquid Anti-Xa
- K213426 — HemosIL ReadiPlasTin
- K203790 — GEM Premier 5000
- DEN190032 — HemosIL Liquid Anti-Xa
- K200033 — HemosIL von Willebrand Factor Antigen
- K183546 — GEM Premier ChemSTAT
- K183549 — GEM Premier ChemSTAT
- K183555 — GEM Premier ChemSTAT
- K180486 — HemosIL Factor XII Deficient Plasma
- K173403 — GEM Premier 5000
- K172903 — HemosIL D-Dimer HS 500
- K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
- K170314 — ACL AcuStar
- K160225 — GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
- K160402 — GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
- K160412 — GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
- K160415 — GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
- K160885 — HemosIL D-Dimer HS
- K161818 — GEM Premier 3000
- K153137 — HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
- K160445 — HemosIL Silica Clotting Time
- K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
- K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- K151534 — HemosIL D-Dimer HS
- K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
- K132722 — HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
- K133407 — GEM PREMIER 4000
- K122584 — HEMOSIL READIPLAS TIN
- K112995 — GEM PREMIER 4000
- K113211 — HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
- K110031 — HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
- K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA
- K102552 — HEMOSIL LA POSITIVE CONTROL
- K102164 — HEMOSIL PROTEIN S ACTIVITY ASSAY
- K093623 — GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
- K091556 — HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
- K093737 — HEMOSIL F11 & FV DNA CONTROL
- K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
- K090264 — HEMOSIL D-DIMER HS 500, CONTROLS
- K090563 — HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
- K091980 — ACL TOP 700 LAS
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
- K083518 — ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
- K082859 — HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
- K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
- K073367 — HEMOSIL FIBRINOGEN-C
- K070927 — HEMOSIL D-DIMER HS
- K070005 — HEMOSIL RECOMBIPLASTIN 2G
- K070635 — HEMOSIL PROCLOT
- K070301 — HEMOSIL ANTITHROMBIN
- K063679 — ACL TOP
- K061598 — HEMOSIL HOMOCYSTEINE AND CONTROLS
- K061974 — GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
- K062430 — HEMOSIL PROTEIN C
- K062431 — HEMOSIL LIQUID ANTITHROMBIN
- K060931 — HEMOSIL PT-FIBRINOGEN HS PLUS
- K060688 — HEMOSIL SYNTHASIL
- K060162 — ACL ELITE; ACL ELITE PRO
- K053499 — HEMOSIL PROS
- K052121 — GEM PREMIER 3000
- K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA
- K050544 — HEMOSIL D-DIMER HS
- K050221 — HEMOSIL SILICA CLOTTING TIME
- K050278 — HEMOSIL D-DIMER
- K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA
- K042982 — QUANTEX MYOGLOBIN
- K043184 — HEMOSIL RECOMBIPLASTIN
- K042576 — COATEST SP FVIII
- K041905 — HEMOSIL CALIBRATION PLASMA
- K040879 — QUANTEX FERRITIN
- K040843 — HEMOSIL VON WILLEBRAND ACTIVITY
- K040359 — HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
- K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA
- K033414 — ACL TOP MODEL, TOP
- K033775 — HEMOSIL LIQUID ANTITHROMBIN XL
- K032663 — QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
- K033631 — MODIFICATION TO COATEST FACTOR VIII
- K032419 — QUANTEX D-DIMER
- K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA
- K030964 — CALIBRATION PLASMA LMW HEPARIN
- K030965 — CONTROL PLASMA LMW HEPARIN
- K031122 — HEMOSIL FACTOR X DEFICIENT PLASMA
- K030287 — HEMOSIL FACTOR XI DEFICIENT PLASMA
- K030215 — BIORAPID MONONUCLEOSIS
- K024082 — HEMOSIL FACTOR VII DEFICIENT PLASMA
- K023839 — HEMOSIL FACTOR V DEFICIENT PLASMA
- K023269 — HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
- K022158 — IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
- K022550 — COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
- K022195 — COAMATIC AT-400
- K021024 — HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
- K021022 — HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
- K021023 — HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
- K012901 — COLOR-MONOGEN
- K012768 — HEMOSIL RECOMBI PLASTIN
- K011424 — IL TEST PROS
Data sourced from openFDA. This site is unofficial and independent of the FDA.