510(k) K171061 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
MRSASelect II
| Applicant | Bio-Rad, 92430 Marnes-La-Coquette, FR |
| Decision | Substantially Equivalent, Dec 28, 2017 |
| Received | Apr 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2018 | Bio-Rad Laboratories, Inc MRSASelect II, IVD, REF 63758 (20 plates per package).
The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and dia Terminated |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.