510(k) K872397 ยท LGQ Fluorescence Polarization Immunoassay, Phenobarbital
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
| Applicant | Roche Diagnostic Systems, Inc., Belleville NJ, US |
| Decision | Substantially Equivalent, Jul 21, 1987 |
| Received | Jun 22, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872397
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.