510(k) K990023 ยท LSK Dna-Reagents, Chlamydia
HYBRID CAPTURE II CT-ID TEST
| Applicant | Digene Corp., Beltsville MD, US |
| Decision | Substantially Equivalent, Oct 25, 1999 |
| Received | Jan 5, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990023
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2003 | Digene Corp Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only). Terminated |
MAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.