510(k) K960989 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST SUBMISSION FOR IMIPENEM
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, May 20, 1996 |
| Received | Mar 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 Open, Classified |
JWY | None listed |
| Mar 21, 2017 | BioMerieux SA ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aero Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.