Medical Device Manufacturer · US , Mchenry , IL

Sigma Chemical Co. - FDA 510(k) Cleared Devices

231 submissions · 231 cleared · Since 1976

Official Website

231

Total

231

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sigma Chemical Co. Hematology ✕

40 devices

1-12 of 40

Cleared Oct 31, 1991

MONOCLONAL ANTIBODY ANTI-CD19

Hematology · 597d

Cleared Oct 31, 1991

MONOCLONAL ANTIBODY ANTI-CD2

Hematology · 597d

Cleared Oct 31, 1991

MONOCLONAL ANTIBODY ANTI-CD5

Hematology · 597d

Cleared Oct 31, 1991

MONOCLONAL ANTIBODY ANTI-CD3

Hematology · 597d

Cleared Nov 08, 1990

Hematology · 49d

Cleared Jul 26, 1990

COAGULATION CONTROL, LEVEL I

Hematology · 58d

Cleared Jul 26, 1990

COAGULATION CONTROL, LEVEL II

Hematology · 58d

Cleared Jul 26, 1990

COAGULATION CONTROL, LEVEL III

Hematology · 58d

Cleared Jul 03, 1990

THROMBOPLASTIN WITH CALCIUM

Hematology · 56d

Cleared Jul 03, 1990

ACCUSCAN MICROBEAD STANDARDS

Hematology · 42d

Cleared Mar 06, 1990

FACTOR V DEFICIENT PLASMA

Hematology · 36d

Cleared Mar 06, 1990

FACTOR VII DEFICIENT PLASMA

Hematology · 36d

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