FDA applicant
Biotecx Laboratories, Inc.
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
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.
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.
See the 510(k) Report