510(k) K043072 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 27, 2005 |
| Received | Nov 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043072
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.