510(k) K926441 ยท KLT Enzyme Immunoassay, Carbamazepine
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, May 26, 1993 |
| Received | Dec 23, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K926441
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.