FDA applicant

Intl. Immunoassay Laboratories, Inc.

Santa Clara, CA27 decisions1980–19920 recalls

FDA records 27 decisions for Intl. Immunoassay Laboratories, Inc. (Santa Clara, CA) from 1980 to 1992: 27 510(k) clearances. Most are in product codes JHX (Fluorometric Method, Cpk Or Isoenzymes) and JHW (U.V. Method, Cpk Isoenzymes). 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 Intl. Immunoassay Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intl. Immunoassay Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Intl. Immunoassay Laboratories, 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

Intl. Immunoassay Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?