Company ยท US
Austin Biological Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1988. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 12 |
| LTW | Susceptibility Test Cards, Antimicrobial | 11 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 7 |
| JSF | Culture Media, Single Biochemical Test | 3 |
| JSE | Culture Media, Multiple Biochemical Test | 2 |
| JSS | Kit, Identification, Enterobacteriaceae | 2 |
| JST | Kit, Fastidious Organisms | 2 |
| JSP | Kit, Anaerobic Identification | 1 |
| JSW | Kit, Identification, Glucose Nonfermenter | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 |
| JSZ | Kit, Identification, Pseudomonas | 1 |
| JTR | Kit, Quality Control For Culture Media | 1 |
| LTD | Paraquat Assay | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 1988 | K880511 | XACT NEISSERIA Austin Biological Laboratories | JSX |
| Feb 18, 1988 | K874727 | PRECEPT(TM) CIPROFLOXACIN Austin Biological Laboratories | JWY |
| Apr 3, 1987 | K870769 | AUSTIN NONFERMENTER KIT Austin Biological Laboratories | JSW |
| Nov 13, 1986 | K864069 | PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID Austin Biological Laboratories | JWY |
| Jul 11, 1986 | K862560 | PRECEPT CEFTIZOXIME Austin Biological Laboratories | JWY |
| Jul 11, 1986 | K862446 | PRECEPT CEFTAZIDIME Austin Biological Laboratories | JWY |
| Feb 20, 1986 | K860195 | PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE Austin Biological Laboratories | JWY |
| Feb 20, 1986 | K860194 | AUSTIN ENTERIC SYSTEM Austin Biological Laboratories | JSE |
| Feb 5, 1986 | K854577 | PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) Austin Biological Laboratories | JWY |
| Sep 16, 1985 | K853772 | PRECEPT METHICILLIN Austin Biological Laboratories | LTW |
| Sep 16, 1985 | K853685 | PRECEPT TM CARBENICILLIN Austin Biological Laboratories | LTW |
| Sep 16, 1985 | K853596 | PRECEPT CEFOPERAZONE Austin Biological Laboratories | LTW |
| Sep 16, 1985 | K853273 | PRECEPT CEFTRIAXONE Austin Biological Laboratories | LTW |
| Sep 13, 1985 | K853689 | PRECEPT TM MOXALACTAM Austin Biological Laboratories | LTW |
| Sep 13, 1985 | K853688 | PRECEPT TM TOBRAMYCIN Austin Biological Laboratories | LTW |
| Sep 13, 1985 | K853687 | PRECEPT NETILMICIN 32-13 Austin Biological Laboratories | LTW |
| Sep 13, 1985 | K853686 | PRECEPT TM AMIKACIN Austin Biological Laboratories | LTW |
| Sep 13, 1985 | K853684 | PRECEPT KANAMYCIN Austin Biological Laboratories | LTW |
| Sep 13, 1985 | K850833 | PRECEPT TM MEZLOCILLIN Austin Biological Laboratories | JWY |
| Aug 29, 1985 | K853263 | PRECEPT AVGMENTIN Austin Biological Laboratories | LTW |
| Aug 29, 1985 | K853053 | PRECEPT ERYTHROMYCIN Austin Biological Laboratories | LTW |
| Mar 5, 1985 | K850052 | ANAEROBE KIT Austin Biological Laboratories | JSP |
| Feb 19, 1985 | K843612 | MODIFICATION OF ABL MIC-10 PRECEPT SYS Austin Biological Laboratories | LTD |
| Oct 1, 1984 | K843571 | RIM-UREA Austin Biological Laboratories | JSS |
| Jul 2, 1984 | K842451 | RIM STREP KIT Austin Biological Laboratories | JSE |
| Jun 19, 1984 | K842098 | RIM H2S Austin Biological Laboratories | JSF |
| Jun 7, 1984 | K842097 | RIM SPOT INDOLE Austin Biological Laboratories | JSF |
| May 2, 1984 | K841460 | RIM GARDNERELLA VAGINALIS KIT Austin Biological Laboratories | JTO |
| May 2, 1984 | K841389 | RIM-DNASE KIT Austin Biological Laboratories | JSF |
| May 2, 1984 | K841329 | RIM ONPG KIT Austin Biological Laboratories | JTO |
| Apr 20, 1984 | K841508 | RIM 6.5% NACL Austin Biological Laboratories | JTO |
| Apr 20, 1984 | K841277 | RIM-HIPPURATE Austin Biological Laboratories | JTO |
| Apr 20, 1984 | K841270 | RIM - NITRATE TEST Austin Biological Laboratories | JTO |
| Apr 20, 1984 | K841262 | RIM-BILE ESCULIN TEST Austin Biological Laboratories | JTO |
| Feb 27, 1984 | K840252 | RIM GRAM REACTION SWAB Austin Biological Laboratories | JTO |
| Oct 4, 1983 | K832587 | RIME COLI KIT Austin Biological Laboratories | JTO |
| Aug 12, 1983 | K832239 | RIM-HAEMOPHILUS 2 Austin Biological Laboratories | JST |
| Aug 12, 1983 | K832051 | RIM-HAEMOPHILUS 1 & 2 Austin Biological Laboratories | JST |
| Jul 28, 1983 | K831653 | LYOPHILIZED MICROORGANISMS Austin Biological Laboratories | JTR |
| Jun 30, 1983 | K831674 | RIM-CAMP TEST Austin Biological Laboratories | JTO |
| Jun 30, 1983 | K831673 | OXY-SWAB Austin Biological Laboratories | JTO |
| Jun 22, 1983 | K831672 | SPECTRUM-10 Austin Biological Laboratories | JSS |
| Jun 22, 1983 | K831654 | RIM BETA LACTAMASE TEST Austin Biological Laboratories | JTO |
| Jun 17, 1983 | K831655 | SPECTRUM-10 Austin Biological Laboratories | JSZ |
| Jun 16, 1983 | K830968 | RAPID IDENTIFI-METHOD NEISSERIA KIT Austin Biological Laboratories | JTO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||