510(k) K061413 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 13, 2006 |
| Received | May 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061413
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.