510(k) K102668 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
| Applicant | BIOMERIEUX, Craponne, FR |
| Decision | Substantially Equivalent, Nov 17, 2010 |
| Received | Sep 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102668
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478 Open, Classified |
JWY | None listed |
| Mar 21, 2017 | BioMerieux SA ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 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.