510(k) K922906 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
| Applicant | Roche Molecular Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jun 15, 1993 |
| Received | Jun 17, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922906
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.