510(k) K081212 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
MRSASELECT - EXTENDED INCUBATION
| Applicant | Bio-Rad, Beverly MA, US |
| Decision | Substantially Equivalent, Jun 13, 2008 |
| Received | Apr 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2018 | Bio-Rad Laboratories, Inc MRSASelect, IVD, REF 63747, containing 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 a Terminated |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.