FDA applicant

Sterling Diagnostics, Inc.

Sterling Heights, MI41 decisions1985–19936 recalls

FDA records 41 decisions for Sterling Diagnostics, Inc. (Sterling Heights, MI) from 1985 to 1993: 41 510(k) clearances. Most are in product codes CEK (Biuret (Colorimetric), Total Protein) and CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme…). 6 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Sterling Diagnostics, Inc. since 2007.

Recalls per year

6in 2016

2007high 6 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sterling Diagnostics, 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 “Sterling”

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

Sterling Medivations, Inc. 27 Sterling Biochemical, Inc. 15 Sterling Drug, Inc. 9 Sterling Diagnostic Imaging, Inc. 7 Sterling Medical Devices, Inc. 2 Sterling U.S.A., Inc. 1 Sterling Medical, Inc. 1 Sterling Multi-Products, Inc. 1

Sterling Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sterling”