510(k) K964422 ยท DIF Drug Mixture Control Materials
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Nov 25, 1996 |
| Received | Nov 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964422
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.