Medical Device Manufacturer · US , Mchenry , IL

Immuno-Mycologics, Inc. - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 1979

Recent clearances: ALPHA CRYPTOCOCCAL ANTIGEN EIA, CRAG LATERAL FLOW ASSAY (LFA), CRAG LATERAL FLOW ASSAY (CRAG LFA)

26

Total

26

Cleared

0

Denied

FDA 510(k) Regulatory Record - Immuno-Mycologics, Inc. Microbiology ✕

26 devices

1-12 of 26

Cleared Dec 17, 2012

ALPHA CRYPTOCOCCAL ANTIGEN EIA

Microbiology · 263d

Cleared Mar 28, 2012

CRAG LATERAL FLOW ASSAY (LFA)

Microbiology · 218d

Cleared Jul 20, 2011

CRAG LATERAL FLOW ASSAY (CRAG LFA)

Microbiology · 342d

Cleared Jul 19, 2011

ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102

Microbiology · 426d

Cleared Aug 25, 1988

RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT

Microbiology · 16d

Cleared Feb 24, 1988

EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001

Microbiology · 50d

Cleared Oct 01, 1984

EI-CANDIDA ENZYME IMMUNOASSAY EI1001

Microbiology · 41d

Cleared Jun 08, 1983

LA-STAPH IDENTIFICATION SYSTEM

Cleared May 05, 1983

LA-HISTO ANTIBODY SYSTEM #HL 1001

Microbiology · 50d

Cleared Mar 20, 1981

YA-CRYPTO ANTIBODY TUBE AGGLUTINATION

Microbiology · 24d

Cleared Oct 31, 1980

LA-SPORO ANTIBODY SYSTEM

Microbiology · 25d

Cleared Jun 02, 1980

CAPIK-CANDIDA ALBICANS IDENT. KIT.

Microbiology · 42d