510(k) K974342 ยท LSL Dna-Reagents, Neisseria
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
| Applicant | Roche Molecular Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, May 28, 1999 |
| Received | Nov 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974342
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.