510(k) K974572 ยท MDK Dna-Probe, Reagents, Streptococcal
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
| Applicant | Chugai Pharmaceuticals Co., Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 24, 1998 |
| Received | Dec 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974572
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2011 | Gen-Probe Inc Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820. Terminated |
MDK | None listed |
| Dec 19, 2007 | Gen-Probe Inc Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121 Terminated |
MDK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.