510(k) K972963 ยท LCM Enzyme Immunoassay, Phencyclidine
MODIFIED CEDIA DAU PCP ASSAY
| Applicant | Boehringer Mannheim Corp., Concord CA, US |
| Decision | Substantially Equivalent, Sep 22, 1997 |
| Received | Aug 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972963
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.