Medical Device Manufacturer · US , Mchenry , IL

American Dade - FDA 510(k) Cleared Devices

149 submissions · 149 cleared · Since 1980

149

Total

149

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Dade Immunology ✕

8 devices

1-8 of 8

Cleared Jul 21, 1987

STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY

Immunology · 61d

Cleared Apr 12, 1985

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO

Immunology · 58d

Cleared Nov 19, 1984

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY

Immunology · 26d

Cleared Nov 19, 1984

SERIES I/S INFECTIONS

Immunology · 14d

Cleared Sep 26, 1984

STRATUS LIDOCAINE FLUOROMETRIC ENZYME

Immunology · 44d

Cleared May 17, 1983

STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-

Immunology · 36d

Cleared May 16, 1983

STRATUS PHENYTOIN FLUOROMETRIC ENZYME

Immunology · 38d

Cleared Nov 02, 1981

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C

Immunology · 55d