510(k) K913459 ยท JWY Manual Antimicrobial Susceptibility Test Systems
THE E TEST, MODIFICATION
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Sep 25, 1991 |
| Received | Aug 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252 Open, Classified |
JWY | None listed |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333 Open, Classified |
JWY | None listed |
| Dec 19, 2017 | BioMerieux SA ETEST OXACILLIN OX 256 US F100
In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species. Terminated |
JWY | None listed |
| Dec 19, 2017 | BioMerieux SA ETEST OXACILLIN OX 256 WW F100
In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species. Terminated |
JWY | None listed |
| Mar 21, 2017 | BioMerieux SA ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-posit Terminated |
JWY | None listed |
| Mar 21, 2017 | BioMerieux SA ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-po Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.