Medical Device Manufacturer · US , Mchenry , IL

American Diagnostic Corp. - FDA 510(k) Cleared Devices

39 submissions · 39 cleared · Since 1980

39

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Diagnostic Corp. Chemistry ✕

17 devices

1-12 of 17

Cleared May 15, 2006

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK

Chemistry · 95d

Cleared Sep 18, 1989

BIOTEL MICROALBUMINURIA (TM)

Chemistry · 95d

Cleared Mar 06, 1987

MAJOR QUALITY GLUCOSE AND KETONES URINE TEST

Chemistry · 30d

Cleared Jun 13, 1986

BIOTEL (TM)/ DIABETES

Chemistry · 164d

Cleared May 09, 1986

BIOTEL (TM)/UTI

Chemistry · 129d

Cleared Sep 12, 1983

QUINIDINE FLUORESCENT IMMUNOASSAY

Chemistry · 47d

Cleared Jun 02, 1983

IGE RADIOIMMUNOASSAY KIT

Chemistry · 36d

Cleared Nov 10, 1982

KENAMYCIN FLUORESCENT IMMUNOASSAY FIA

Chemistry · 23d

Cleared Oct 26, 1982

NETILMICIN FLUORESCENT IMMUNOASSAY

Chemistry · 22d

Cleared Jul 02, 1982

AMERIFLOUR FLUOROMETER

Chemistry · 15d

Cleared Mar 02, 1982

AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM

Chemistry · 19d

Cleared Dec 31, 1981

Chemistry · 10d