510(k) K831934 ยท KLS Enzyme Immunoassay, Theophylline
THEOPHYLLINE TEST PACK ACA
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 12, 1983 |
| Received | Jun 15, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831934
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.