Medical Device Manufacturer · US , Romeo , MI

Macomb Biotechnology, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1987

Recent clearances: MODIFIED HEMOGLOBIN REAGENT SET, THE URIC ACID REAGENT SET

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Macomb Biotechnology, Inc. Chemistry ✕

1 devices

1-1 of 1

Cleared Jun 03, 1987

THE URIC ACID REAGENT SET

Chemistry · 19d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Oct 19, 2026