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. Immunology ✕

4 devices

1-4 of 4

Cleared Jan 20, 1995

Immunology · 213d

Cleared Dec 02, 1994

Immunology · 147d

Cleared Nov 04, 1987

NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)

Immunology · 26d

Cleared Mar 28, 1986

NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM

Immunology · 73d