Medical Device Manufacturer · US , Mchenry , IL

Immunotech Corp. - FDA 510(k) Cleared Devices

37 submissions · 37 cleared · Since 1980

Recent clearances: OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL, OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES, OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES

37

Total

37

Cleared

0

Denied

FDA 510(k) Regulatory Record - Immunotech Corp. Immunology ✕

5 devices

1-5 of 5

Cleared Jan 30, 1991

MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT

Immunology · 34d

Cleared Dec 18, 1990

MICROZYME T3 ENZYME IMMUNOASSAY KIT

Immunology · 55d

Cleared May 13, 1982

ENDAB T4 ENZYME IMMUNOASSAY KIT

Immunology · 22d

Cleared Oct 31, 1980

ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT

Immunology · 23d

Cleared Oct 23, 1980

ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY

Immunology · 57d