510(k) K862528 ยท LGQ Fluorescence Polarization Immunoassay, Phenobarbital
IMMPULSE PHENOBARBITAL ASSAY REAGENTS
| Applicant | Sclavo, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 16, 1986 |
| Received | Jul 2, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862528
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.