FDA applicant
Austin Biological Laboratories
FDA records 45 decisions for Austin Biological Laboratories (Austin, TX) from 1983 to 1988: 45 510(k) clearances. Most are in product codes JTO (Discs, Strips And Reagents, Microorganism…) and LTW (Susceptibility Test Cards, Antimicrobial). 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 Austin Biological Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Austin Biological Laboratories since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Austin Biological Laboratories’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) ReportOther applicant names beginning “Austin”
FDA records each applicant name separately; these may or may not be the same firm.