FDA applicant

Stat Chem, Inc.

Orange, CA1 decision2004–20040 recalls

FDA records 1 decision for Stat Chem, Inc. (Orange, CA) in 2004: 1 510(k) clearance. All are in product code CEM (Electrode, Ion Specific, Potassium). Its devices cite 3 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 Stat Chem, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stat Chem, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stat Chem, 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

Other applicant names beginning “Stat”

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

Stat Medical Devices 4 Stat Medical Corp. 4 Stat Path 4 Stat Engineering 1 Stat-Spin Technologies 1

Stat Chem, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Stat”