510(k) K864612 ยท LFN Nephelometric Inhibition Immunoassay, Phenobarbital
DART PHENOBARBITAL ASSAY SYSTEM
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Jan 13, 1987 |
| Received | Nov 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864612
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.