510(k) K964355 ยท LCM Enzyme Immunoassay, Phencyclidine
ONTRAK TESTCUP 5 (MODIFICATION)
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 13, 1996 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964355
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.