510(k) K964507 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
| Applicant | Roche Molecular Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jun 13, 1997 |
| Received | Nov 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964507
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.