510(k) K872628 ยท LSL Dna-Reagents, Neisseria
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Dec 21, 1987 |
| Received | Jul 6, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872628
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.