510(k) K994017 ยท LCM Enzyme Immunoassay, Phencyclidine
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 27, 2000 |
| Received | Nov 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994017
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.