510(k) Report

FDA applicant

Biotecx Laboratories, Inc.

Friendswood, TX15 decisions1978–19990 recalls

FDA records 15 decisions for Biotecx Laboratories, Inc. (Friendswood, TX) from 1978 to 1999: 15 510(k) clearances. Most are in product codes JLS (Radioimmunoassay, Progesterone) and CGR (Radioimmunoassay, Cortisol). 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 Biotecx Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotecx Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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