I M, Inc. - FDA 510(k) Cleared Devices
Recent clearances: NEUROLOGICAL SPONGE, BIOPSY KIT, SYRINGE PREFILLED WITH WATER
41
Total
40
Cleared
0
Denied
FDA 510(k) Regulatory Record - I M, Inc. Immunology ✕
15 devices
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
Cleared
Nov 01, 1976
ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL)
Immunology
19d
Cleared
Nov 01, 1976
ANTI-ASPERGILLUS CONT. SER. (MYCELIAL)
Immunology
19d
Cleared
Nov 01, 1976
NEGATIVE CONTROL SERUM
Immunology
19d