Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Austin Biological Laboratories · Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
196 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880511 | XACT NEISSERIA | Austin Biological Laboratories | 1988-08-25 | 198 | 0 |
| K874727 | PRECEPT(TM) CIPROFLOXACIN | Austin Biological Laboratories | 1988-02-18 | 92 | 0 |
| K870769 | AUSTIN NONFERMENTER KIT | Austin Biological Laboratories | 1987-04-03 | 36 | 0 |
| K864069 | PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID | Austin Biological Laboratories | 1986-11-13 | 24 | 0 |
| K862446 | PRECEPT CEFTAZIDIME | Austin Biological Laboratories | 1986-07-11 | 14 | 0 |
| K862560 | PRECEPT CEFTIZOXIME | Austin Biological Laboratories | 1986-07-11 | 8 | 0 |
| K860195 | PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE | Austin Biological Laboratories | 1986-02-20 | 29 | 0 |
| K860194 | AUSTIN ENTERIC SYSTEM | Austin Biological Laboratories | 1986-02-20 | 29 | 0 |
| K854577 | PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) | Austin Biological Laboratories | 1986-02-05 | 105 | 0 |
| K853596 | PRECEPT CEFOPERAZONE | Austin Biological Laboratories | 1985-09-16 | 20 | 0 |
| K853273 | PRECEPT CEFTRIAXONE | Austin Biological Laboratories | 1985-09-16 | 42 | 0 |
| K853685 | PRECEPT TM CARBENICILLIN | Austin Biological Laboratories | 1985-09-16 | 178 | 0 |
| K853772 | PRECEPT METHICILLIN | Austin Biological Laboratories | 1985-09-16 | 147 | 0 |
| K853689 | PRECEPT TM MOXALACTAM | Austin Biological Laboratories | 1985-09-13 | 196 | 0 |
| K850833 | PRECEPT TM MEZLOCILLIN | Austin Biological Laboratories | 1985-09-13 | 196 | 0 |
| K853686 | PRECEPT TM AMIKACIN | Austin Biological Laboratories | 1985-09-13 | 175 | 0 |
| K853684 | PRECEPT KANAMYCIN | Austin Biological Laboratories | 1985-09-13 | 175 | 0 |
| K853687 | PRECEPT NETILMICIN 32-13 | Austin Biological Laboratories | 1985-09-13 | 196 | 0 |
| K853688 | PRECEPT TM TOBRAMYCIN | Austin Biological Laboratories | 1985-09-13 | 196 | 0 |
| K853053 | PRECEPT ERYTHROMYCIN | Austin Biological Laboratories | 1985-08-29 | 41 | 0 |
| K853263 | PRECEPT AVGMENTIN | Austin Biological Laboratories | 1985-08-29 | 24 | 0 |
| K850052 | ANAEROBE KIT | Austin Biological Laboratories | 1985-03-05 | 56 | 0 |
| K843612 | MODIFICATION OF ABL MIC-10 PRECEPT SYS | Austin Biological Laboratories | 1985-02-19 | 159 | 0 |
| K843571 | RIM-UREA | Austin Biological Laboratories | 1984-10-01 | 20 | 0 |
| K842451 | RIM STREP KIT | Austin Biological Laboratories | 1984-07-02 | 10 | 0 |
| K842098 | RIM H2S | Austin Biological Laboratories | 1984-06-19 | 25 | 0 |
| K842097 | RIM SPOT INDOLE | Austin Biological Laboratories | 1984-06-07 | 13 | 0 |
| K841460 | RIM GARDNERELLA VAGINALIS KIT | Austin Biological Laboratories | 1984-05-02 | 23 | 0 |
| K841389 | RIM-DNASE KIT | Austin Biological Laboratories | 1984-05-02 | 29 | 0 |
| K841329 | RIM ONPG KIT | Austin Biological Laboratories | 1984-05-02 | 30 | 0 |
| K841277 | RIM-HIPPURATE | Austin Biological Laboratories | 1984-04-20 | 23 | 0 |
| K841262 | RIM-BILE ESCULIN TEST | Austin Biological Laboratories | 1984-04-20 | 25 | 0 |
| K841508 | RIM 6.5% NACL | Austin Biological Laboratories | 1984-04-20 | 9 | 0 |
| K841270 | RIM - NITRATE TEST | Austin Biological Laboratories | 1984-04-20 | 24 | 0 |
| K840252 | RIM GRAM REACTION SWAB | Austin Biological Laboratories | 1984-02-27 | 35 | 0 |
| K832587 | RIME COLI KIT | Austin Biological Laboratories | 1983-10-04 | 63 | 0 |
| K832239 | RIM-HAEMOPHILUS 2 | Austin Biological Laboratories | 1983-08-12 | 46 | 0 |
| K832051 | RIM-HAEMOPHILUS 1 & 2 | Austin Biological Laboratories | 1983-08-12 | 49 | 0 |
| K831653 | LYOPHILIZED MICROORGANISMS | Austin Biological Laboratories | 1983-07-28 | 66 | 0 |
| K831674 | RIM-CAMP TEST | Austin Biological Laboratories | 1983-06-30 | 38 | 0 |
| K831673 | OXY-SWAB | Austin Biological Laboratories | 1983-06-30 | 38 | 0 |
| K831672 | SPECTRUM-10 | Austin Biological Laboratories | 1983-06-22 | 30 | 0 |
| K831654 | RIM BETA LACTAMASE TEST | Austin Biological Laboratories | 1983-06-22 | 30 | 0 |
| K831655 | SPECTRUM-10 | Austin Biological Laboratories | 1983-06-17 | 25 | 0 |
| K830968 | RAPID IDENTIFI-METHOD NEISSERIA KIT | Austin Biological Laboratories | 1983-06-16 | 80 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda