Sigma Diagnostics, Inc.
FDA 510(k) medical device clearances.
Top product codes for Sigma Diagnostics, Inc.
Recent clearances by Sigma Diagnostics, Inc.
1–100 of 164- K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
- K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
- K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
- K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
- K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
- K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B
- K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
- K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540
- K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
- K003328 — ACCUCLOT CONTROL I, MODEL A4089
- K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
- K001403 — SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
- K993741 — EZ LDL CHOLESTEROL TEST SYSTEM
- K001569 — INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
- K000527 — ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
- K000528 — ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
- K992711 — SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
- K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
- K992798 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
- K992800 — SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
- K992801 — SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
- K992803 — SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
- K984574 — INFINITY GLUCOSE REAGENT
- K982209 — ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
- K982251 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
- K982236 — SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
- K981248 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
- K981254 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
- K981255 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
- K980667 — INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
- K980666 — INFINITY AST REAGENT (PROCEDURE NO. 51)
- K973274 — ACCUCOLOR HIGH CALIBRATOR (A3089)
- K972260 — CS-400 COAGULATION ANALYZER SYSTEM (A1208)
- K972796 — SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
- K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
- K972743 — SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
- K972794 — DIGOXIN DG-II FPIA REAGENT SET
- K972132 — SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS
- K972144 — SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
- K972041 — EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
- K963535 — SIGMA DIAGNOSTICS GLUCOSE REAGENT
- K963539 — SIGMA DIAGNOSTICS WASH CONCENTRATE
- K963543 — SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
- K963533 — SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
- K963537 — SIGMA DIAGNOSTICS BUN REAGENT
- K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT
- K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
- K963536 — SIGMA DIAGNOSTICS CALICIUM REAGENT
- K963534 — SIGMA DIAGNOSTICS CREATININE REAGENT KIT
- K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
- K963542 — SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
- K960875 — KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
- K955720 — AMAX CS-190 COAGULATION ANALYZER SYSTEM
- K955724 — KC 1A COAGULATION ANALYZER/SET
- K955735 — KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
- K954840 — ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
- K955716 — VANCOMYCIN FPIA REAGENT SET
- K952557 — TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
- K954839 — ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
- K951584 — ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
- K933934 — GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
- K945908 — GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
- K950028 — PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
- K942908 — IGM RF EIA
- K943291 — ANTI DS-DNA
- K943550 — GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
- K943866 — VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
- K944063 — FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
- K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
- K943313 — PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
- K935984 — GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
- K940840 — ACT CONTROL SET
- K940569 — DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
- K942192 — THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
- K932603 — APOLIPOPROTIEN B (APO B)
- K932606 — APOLIPOPROTIEN A-1 (APO A-1)
- K935308 — ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
- K941085 — LIPASE-PS ASSAY PROCEDURE NO. 805
- K935057 — FACTOR VIII DEFICIENT PLASMA
- K935054 — FACTOR X DEFICIENT PLASMA
- K935056 — FACTOR VII DEFICIENT PLASMA
- K935058 — FACTOR
- K933425 — AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
- K932517 — IRON/UIBC REAGENT
- K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
- K932067 — ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
- K930212 — THROMBOPLATIN-M WITH CALCIUM
- K915462 — FIBRINOGEN CONTROL
- K915380 — MICROPROTEIN-PR
- K915465 — DIGITOXIN FPIA REAGENT SET
- K915463 — ACTIVATED PARTIAL THROMBOPLASTIN TIME
- K915464 — DIGITOXIN FPIA CALIBRATOR SET
- K914777 — SIGMA PROCEDURE NO. 333-UV
- K913061 — FIBRINOGEN DETERMINATION KIT
- K913858 — AMYLASE REAGENT (PROCEDURE 577)
- K912061 — HEPARIN ADSORBENT
- K910741 — HEPARIN CONTROLS, HIGH AND LOW
- K910255 — FLOW CYTOMETRY FITC/PE COMPENSATION KIT
- K897147 — SIGMA PROCEDURE NO. 735
- K894204 — CALCIUM (ARSENAZO III) REAGENT
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