Austin Biological Laboratories
Fort Worth, TX, US
Austin Biological Laboratories appears in FDA device records in Fort Worth, TX. FDA records list 45 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 45
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 45 510(k) clearances for Austin Biological Laboratories between 1983 and 1988. The busiest year on record is 1985, with 14. The most recent is 1988, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 10 |
| 1984 | 12 |
| 1985 | 14 |
| 1986 | 6 |
| 1987 | 1 |
| 1988 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K880511 | XACT NEISSERIA | JSX | Substantially Equivalent | |
| K874727 | PRECEPT(TM) CIPROFLOXACIN | JWY | Substantially Equivalent | |
| K870769 | AUSTIN NONFERMENTER KIT | JSW | Substantially Equivalent | |
| K864069 | PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID | JWY | Substantially Equivalent | |
| K862560 | PRECEPT CEFTIZOXIME | JWY | Substantially Equivalent | |
| K862446 | PRECEPT CEFTAZIDIME | JWY | Substantially Equivalent | |
| K860195 | PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE | JWY | Substantially Equivalent | |
| K860194 | AUSTIN ENTERIC SYSTEM | JSE | Substantially Equivalent | |
| K854577 | PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) | JWY | Substantially Equivalent | |
| K853772 | PRECEPT METHICILLIN | LTW | Substantially Equivalent | |
| K853685 | PRECEPT TM CARBENICILLIN | LTW | Substantially Equivalent | |
| K853596 | PRECEPT CEFOPERAZONE | LTW | Substantially Equivalent | |
| K853273 | PRECEPT CEFTRIAXONE | LTW | Substantially Equivalent | |
| K853689 | PRECEPT TM MOXALACTAM | LTW | Substantially Equivalent | |
| K853688 | PRECEPT TM TOBRAMYCIN | LTW | Substantially Equivalent | |
| K853687 | PRECEPT NETILMICIN 32-13 | LTW | Substantially Equivalent | |
| K853686 | PRECEPT TM AMIKACIN | LTW | Substantially Equivalent | |
| K853684 | PRECEPT KANAMYCIN | LTW | Substantially Equivalent | |
| K850833 | PRECEPT TM MEZLOCILLIN | JWY | Substantially Equivalent | |
| K853263 | PRECEPT AVGMENTIN | LTW | Substantially Equivalent | |
| K853053 | PRECEPT ERYTHROMYCIN | LTW | Substantially Equivalent | |
| K850052 | ANAEROBE KIT | JSP | Substantially Equivalent | |
| K843612 | MODIFICATION OF ABL MIC-10 PRECEPT SYS | LTD | Substantially Equivalent | |
| K843571 | RIM-UREA | JSS | Substantially Equivalent | |
| K842451 | RIM STREP KIT | JSE | Substantially Equivalent | |
| K842098 | RIM H2S | JSF | Substantially Equivalent | |
| K842097 | RIM SPOT INDOLE | JSF | Substantially Equivalent | |
| K841460 | RIM GARDNERELLA VAGINALIS KIT | JTO | Substantially Equivalent | |
| K841389 | RIM-DNASE KIT | JSF | Substantially Equivalent | |
| K841329 | RIM ONPG KIT | JTO | Substantially Equivalent | |
| K841508 | RIM 6.5% NACL | JTO | Substantially Equivalent | |
| K841277 | RIM-HIPPURATE | JTO | Substantially Equivalent | |
| K841270 | RIM - NITRATE TEST | JTO | Substantially Equivalent | |
| K841262 | RIM-BILE ESCULIN TEST | JTO | Substantially Equivalent | |
| K840252 | RIM GRAM REACTION SWAB | JTO | Substantially Equivalent | |
| K832587 | RIME COLI KIT | JTO | Substantially Equivalent | |
| K832239 | RIM-HAEMOPHILUS 2 | JST | Substantially Equivalent | |
| K832051 | RIM-HAEMOPHILUS 1 & 2 | JST | Substantially Equivalent | |
| K831653 | LYOPHILIZED MICROORGANISMS | JTR | Substantially Equivalent | |
| K831674 | RIM-CAMP TEST | JTO | Substantially Equivalent | |
| K831673 | OXY-SWAB | JTO | Substantially Equivalent | |
| K831672 | SPECTRUM-10 | JSS | Substantially Equivalent | |
| K831654 | RIM BETA LACTAMASE TEST | JTO | Substantially Equivalent | |
| K831655 | SPECTRUM-10 | JSZ | Substantially Equivalent | |
| K830968 | RAPID IDENTIFI-METHOD NEISSERIA KIT | JTO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JSECulture Media, Multiple Biochemical Test
- JSFCulture Media, Single Biochemical Test
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- JSPKit, Anaerobic Identification
- JSTKit, Fastidious Organisms
- JSSKit, Identification, Enterobacteriaceae
- JSWKit, Identification, Glucose Nonfermenter
- JSXKit, Identification, Neisseria Gonorrhoeae
- JSZKit, Identification, Pseudomonas
- JTRKit, Quality Control For Culture Media
- JWYManual Antimicrobial Susceptibility Test Systems
- LTDParaquat Assay
- LTWSusceptibility Test Cards, Antimicrobial
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain