510(k) K865102 ยท LES Fluorescent Immunoassay, Diphenylhydantoin
IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
| Applicant | Sclavo, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 13, 1987 |
| Received | Dec 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K865102
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.