510(k) K981135 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST BENZYLPENICILLIN
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Jun 9, 1998 |
| Received | Mar 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262 Open, Classified |
JWY | None listed |
| Mar 21, 2017 | BioMerieux SA ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negat Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.