510(k) K980345 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST CEFTRIAXONE
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, May 27, 1998 |
| Received | Jan 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2017 | BioMerieux SA ETEST Ceftriaxone TXL32 SPB, Product Name: ETEST Ceftriaxone TX 0.002-32(low).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aer Terminated |
JWY | None listed |
| Mar 21, 2017 | BioMerieux SA ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-p Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.