510(k) K972359 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
| Applicant | Remel, L.P., Lenexa KS, US |
| Decision | Substantially Equivalent, Aug 28, 1997 |
| Received | Jun 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2021 | Remel Inc Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identificat Terminated |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.