510(k) K053446 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 25, 2006 |
| Received | Dec 12, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053446
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.