510(k) K962165 ยท DIF Drug Mixture Control Materials
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jun 26, 1996 |
| Received | Jun 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962165
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.