510(k) K921435 ยท LQF Dna-Reagents, Mycobacterium Spp.
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 23, 1992 |
| Received | Mar 25, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2011 | Gen-Probe Inc Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835. Terminated |
LQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.