510(k) Report

FDA applicant

Raichem

San Diego, CA1 decision1998–19980 recalls

FDA records 1 decision for Raichem (San Diego, CA) in 1998: 1 510(k) clearance. All are in product code JIX (Calibrator, Multi-Analyte Mixture). Its devices cite 2 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 Raichem’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Raichem since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JIXCalibrator, Multi-Analyte Mixture1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K982767Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol CalibratorRaichem · 1998

The one decision as Raichem →