510(k) K092407 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
REMEL SPECTRA MRSA
| Applicant | Remel, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Oct 8, 2010 |
| Received | Aug 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2011 | Remel Inc Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS.
The product is a selective and differential chromogeni Terminated |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.