Medical Device Manufacturer · US , Mchenry , IL

I M, Inc. - FDA 510(k) Cleared Devices

41 submissions · 40 cleared · Since 1976

41

Total

40

Cleared

0

Denied

FDA 510(k) Regulatory Record - I M, Inc. Immunology ✕

15 devices

1-12 of 15

Cleared Nov 16, 1976

FUNGAL IMMUNODIFFUSION KIT

Immunology · 34d

Cleared Nov 16, 1976

POTASSIUM HYDROXIDE W/GLYCEROL MTG FL.

Immunology · 34d

Cleared Nov 16, 1976

LACTO-PHENOL COTTON BLUE MOUNTING FL.

Immunology · 34d

Cleared Nov 16, 1976

VASPAR, SEALANT FOR FERMENTATIONS

Immunology · 34d

Cleared Nov 01, 1976

HISTOPLASMA MYCELIAL ANTIGEN

Immunology · 19d

Cleared Nov 01, 1976

HISTOPLASMA YEAST ANTIGEN

Immunology · 19d

Cleared Nov 01, 1976

BLASTOMYCES YEAST ANTIGEN

Immunology · 19d

Cleared Nov 01, 1976

COCCIDIOIDES MYCELIAL ANTIGEN

Immunology · 19d

Cleared Nov 01, 1976

ASPERGILLUS MYCELIAL ANTIGEN

Immunology · 19d

Cleared Nov 01, 1976

ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)

Immunology · 19d

Cleared Nov 01, 1976

ANTI-HISTOPLASMA CONTROL SERUM (YEAST)

Immunology · 19d

Cleared Nov 01, 1976

ANTI-BLASTOMYCES CONTROL SERUM (YEAST)

Immunology · 19d