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Sigma Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
164
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION AAugust 30, 2002
K020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLFebruary 6, 2002
K013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971December 26, 2001
K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221November 15, 2001
K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096November 15, 2001
K012410INFINITY HBA KIT, MODELS 537-A, 537-BOctober 26, 2001
K010652SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936March 30, 2001
K010158THROMBOMAX-HS WITH CALCIUM, MODEL T6540March 22, 2001
K003267SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-AMarch 15, 2001
K003328ACCUCLOT CONTROL I, MODEL A4089March 1, 2001
K003329SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217March 1, 2001
K001403SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100PAugust 10, 2000
K993741EZ LDL CHOLESTEROL TEST SYSTEMJuly 3, 2000
K001569INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)June 26, 2000
K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094April 7, 2000
K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119April 7, 2000
K992712SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334December 6, 1999
K992711SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094December 6, 1999
K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, September 28, 1999
K992800SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100PSeptember 28, 1999