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. Chemistry ✕

86 devices

1-12 of 86

Cleared Mar 30, 2001

SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936

Chemistry · 25d

Cleared Aug 10, 2000

SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P,...

Chemistry · 99d

Cleared Jul 03, 2000

EZ LDL CHOLESTEROL TEST SYSTEM

Chemistry · 242d

Cleared Jun 26, 2000

INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)

Chemistry · 38d

Cleared Sep 28, 1999

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P,...

Chemistry · 40d

Cleared Sep 28, 1999

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P,...

Chemistry · 40d

Cleared Sep 28, 1999

SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS...

Chemistry · 40d

Cleared Sep 13, 1999

SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P,...

Chemistry · 25d

Cleared Feb 11, 1999

INFINITY GLUCOSE REAGENT

Chemistry · 50d

Cleared Aug 18, 1998

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT

Chemistry · 53d

Cleared Aug 05, 1998

SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT

Chemistry · 41d

Cleared Apr 21, 1998

INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)

Chemistry · 60d

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