510(k) K864409 ยท LER Fluorescent Immunoassay, Theophylline
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
| Applicant | Sclavo, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 22, 1986 |
| Received | Nov 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864409
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.