510(k) K874267 ยท LCM Enzyme Immunoassay, Phencyclidine
REVISED LABELING FOR PCP TEST KIT
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Nov 13, 1987 |
| Received | Oct 20, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874267
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.