510(k) K063675 ยท LJP Antiserum, Fluorescent, Chlamydia Trachomatis
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
| Applicant | Diagnostic Hybrids, Inc., Athens OH, US |
| Decision | Substantially Equivalent, Sep 24, 2007 |
| Received | Dec 11, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063675
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.