510(k) K081325 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Jul 24, 2008 |
| Received | May 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081325
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2017 | BioMerieux SA ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.