510(k) K936130 ยท LGQ Fluorescence Polarization Immunoassay, Phenobarbital
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Mar 11, 1994 |
| Received | Dec 23, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936130
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.