510(k) K862955 ยท KLS Enzyme Immunoassay, Theophylline
METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Sep 25, 1986 |
| Received | Aug 5, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862955
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.