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Sigma Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 164 products

Total Devices164
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K021162 AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDJPA2002-08-30 View
510(k) K020109 SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLGGC2002-02-06 View
510(k) K013549 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971DAP2001-12-26 View
510(k) K013544 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096DAP2001-11-15 View
510(k) K013545 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221DAP2001-11-15 View
510(k) K012410 INFINITY HBA KIT, MODELS 537-A, 537-BLCP2001-10-26 View
510(k) K010652 SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936JIX2001-03-30 View
510(k) K010158 THROMBOMAX-HS WITH CALCIUM, MODEL T6540GGO2001-03-22 View
510(k) K003267 SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-ADAP2001-03-15 View
510(k) K003328 ACCUCLOT CONTROL I, MODEL A4089GIZ2001-03-01 View
510(k) K003329 SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217GGC2001-03-01 View
510(k) K001403 SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100PCFR2000-08-10 View
510(k) K993741 EZ LDL CHOLESTEROL TEST SYSTEMMRR2000-07-03 View
510(k) K001569 INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)JFJ2000-06-26 View
510(k) K000528 ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119GIR2000-04-07 View
510(k) K000527 ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094GIR2000-04-07 View
510(k) K992711 SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094GFO1999-12-06 View
510(k) K992712 SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334GFO1999-12-06 View
510(k) K992801 SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5CIT1999-09-28 View
510(k) K992798 SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PCDO1999-09-28 View
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