510(k) K063451 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 22, 2007 |
| Received | Nov 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063451
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.