510(k) K945433 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Mar 17, 1995 |
| Received | Oct 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2017 | BioMerieux SA Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058
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.