510(k) K864597 ยท LQF Dna-Reagents, Mycobacterium Spp.
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 20, 1987 |
| Received | Nov 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864597
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.