510(k) K162076 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
chromID MRSA
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Oct 25, 2016 |
| Received | Jul 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841 Open, Classified |
JSO | None listed |
| Jan 4, 2023 | Biomerieux Inc PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524 Open, Classified |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.