510(k) K020748 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST ERTAPENEM
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Apr 29, 2002 |
| Received | Mar 7, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020748
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331 Open, Classified |
JWY | None listed |
| May 3, 2017 | BioMerieux SA ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria
( Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.