FDA applicant

A-Kem, Inc.

Clifton, NJ13 decisions1987–19880 recalls

FDA records 13 decisions for A-Kem, Inc. (Clifton, NJ) from 1987 to 1988: 13 510(k) clearances. Most are in product codes JFL (Ph Rate Measurement, Carbon-Dioxide) and CIX (Bromcresol Green Dye-Binding, Albumin). 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, clinical chemistry panel, where it files most

How often FDA has decided A-Kem, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for A-Kem, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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A-Kem, Inc.

Which product codes does it file in?

What has FDA decided for it lately?