510(k) K981138 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST CIPROFLOXACIN
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Jun 5, 1998 |
| Received | Mar 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981138
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2017 | BioMerieux SA Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 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.