510(k) K980348 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST VANCOMYCIN
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, May 29, 1998 |
| Received | Jan 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980348
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486 Open, Classified |
JWY | None listed |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 Open, Classified |
JWY | None listed |
| Mar 21, 2017 | BioMerieux SA ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positi Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.