FDA applicant

Macomb Biotechnology, Inc.

Romeo, MI2 decisions1987–19890 recalls

FDA records 2 decisions for Macomb Biotechnology, Inc. (Romeo, MI) from 1987 to 1989: 2 510(k) clearances. Most are in product codes GKK (Cyanomethemoglobin) and KNK (Acid, Uric, Uricase (Colorimetric)). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Macomb Biotechnology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macomb Biotechnology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Macomb Biotechnology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Macomb”

FDA records each applicant name separately; these may or may not be the same firm.

Macomb Chemical Co. 23

Macomb Biotechnology, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Macomb”