510(k) K871447 ยท JSD Culture Media, Selective Broth
TODD HEWITT W/CNA (LIM BROTH)
| Applicant | Remel Co., Lenexa KS, US |
| Decision | Substantially Equivalent, May 13, 1987 |
| Received | Apr 13, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871447
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2023 | Remel, Inc remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora Open, Classified |
JSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.