Medical Device Manufacturer · US , Mchenry , IL

Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices

164 submissions · 164 cleared · Since 1984

164

Total

164

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sigma Diagnostics, Inc. Hematology ✕

42 devices

1-12 of 42

Cleared Aug 30, 2002

AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU,...

Hematology · 141d

Cleared Feb 06, 2002

SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL

Hematology · 26d

Cleared Dec 26, 2001

SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971

Hematology · 63d

Cleared Nov 15, 2001

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096

Hematology · 22d

Cleared Nov 15, 2001

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221

Hematology · 22d

Cleared Oct 26, 2001

INFINITY HBA KIT, MODELS 537-A, 537-B

Hematology · 88d

Cleared Mar 22, 2001

THROMBOMAX-HS WITH CALCIUM, MODEL T6540

Hematology · 64d

Cleared Mar 15, 2001

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

Hematology · 148d

Cleared Mar 01, 2001

ACCUCLOT CONTROL I, MODEL A4089

Hematology · 128d

Cleared Mar 01, 2001

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217

Hematology · 128d

Cleared Apr 07, 2000

ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094

Hematology · 50d

Cleared Apr 07, 2000

ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119

Hematology · 50d

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