FDA applicant

Genchem, Inc.

Brea, CA8 decisions2004–20090 recalls

FDA records 8 decisions for Genchem, Inc. (Brea, CA) from 2004 to 2009: 8 510(k) clearances. Most are in product codes JGS (Electrode, Ion Specific, Sodium) and JIX (Calibrator, Multi-Analyte Mixture). Its devices cite 7 predicates, 0 of them its own earlier devices. 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 Genchem, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Genchem, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Genchem, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?