FDA applicant

Photec Diagnostics, Inc.

Little Falls, NJ12 decisions1985–19900 recalls

FDA records 12 decisions for Photec Diagnostics, Inc. (Little Falls, NJ) from 1985 to 1990: 12 510(k) clearances. Most are in product codes DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). 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 Photec Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Photec Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?