Medical Device Manufacturer · US , Westbrook , ME

Immunotech, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1995

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Immunotech, Inc. Hematology ✕

3 devices

1-3 of 3

Cleared Oct 20, 1995

OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES

Hematology · 295d

Cleared Sep 08, 1995

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL

Hematology · 44d

Cleared Jul 05, 1995

OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES

Hematology · 57d