510(k) K973718 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
| Applicant | Roche Molecular Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 15, 1998 |
| Received | Sep 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973718
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.