510(k) K983704 ยท JCM Control, Hemoglobin, Abnormal
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Feb 10, 1999 |
| Received | Oct 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983704
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.