510(k) K010891 ยท LSK Dna-Reagents, Chlamydia
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
| Applicant | Digene Corp., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Sep 25, 2001 |
| Received | Mar 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010891
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.