Austin Biological Laboratories: FDA clearances and approvals
Austin Biological Laboratories has 45 FDA 510(k) clearances (first 1983, latest 1988), across 13 product codes in 2 review panels. Median 510(k) review time: 36 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 12 | 12 |
| LTW | Susceptibility Test Cards, Antimicrobial | 11 | 11 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 7 | 7 |
| JSF | Culture Media, Single Biochemical Test | 3 | 3 |
| JSE | Culture Media, Multiple Biochemical Test | 2 | 2 |
| JSS | Kit, Identification, Enterobacteriaceae | 2 | 2 |
| JST | Kit, Fastidious Organisms | 2 | 2 |
| JSP | Kit, Anaerobic Identification | 1 | 1 |
| JSW | Kit, Identification, Glucose Nonfermenter | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 1 |
Plus 3 more product codes.
Review panels
- Microbiology (44)
- Clinical Toxicology (1)
Most recent Austin Biological Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880511 | XACT NEISSERIA | JSX | 1988-08-25 | 198 |
| K874727 | PRECEPT(TM) CIPROFLOXACIN | JWY | 1988-02-18 | 92 |
| K870769 | AUSTIN NONFERMENTER KIT | JSW | 1987-04-03 | 36 |
| K864069 | PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID | JWY | 1986-11-13 | 24 |
| K862560 | PRECEPT CEFTIZOXIME | JWY | 1986-07-11 | 8 |
| K862446 | PRECEPT CEFTAZIDIME | JWY | 1986-07-11 | 14 |
| K860195 | PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE | JWY | 1986-02-20 | 29 |
| K860194 | AUSTIN ENTERIC SYSTEM | JSE | 1986-02-20 | 29 |
| K854577 | PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) | JWY | 1986-02-05 | 105 |
| K853772 | PRECEPT METHICILLIN | LTW | 1985-09-16 | 147 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Austin Biological Laboratories.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Austin Biological Laboratories have?
Austin Biological Laboratories has 45 FDA 510(k) clearances (first 1983, latest 1988), across 13 product codes in 2 review panels.
How long does FDA take to clear Austin Biological Laboratories's 510(k)s?
The median time from FDA receipt to decision across Austin Biological Laboratories's cleared 510(k)s is 36 days.
What devices does Austin Biological Laboratories make?
Its most frequent FDA product codes are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 12); LTW (Susceptibility Test Cards, Antimicrobial, 11); JWY (Manual Antimicrobial Susceptibility Test Systems, 7).
Has Austin Biological Laboratories had device recalls?
openFDA lists no recalls under a recalling firm name matching Austin Biological Laboratories. Related entities may recall under other names.
Next steps
- See all 45 Austin Biological Laboratories clearances with predicates and recalls
- Run predicate analysis for product code JTO, Austin Biological Laboratories's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.