510(k) K952596 ยท KLS Enzyme Immunoassay, Theophylline
THEOPHYLLINE ENZYME IMMUNOASSAY
| Applicant | Diagnostic Reagents, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 11, 1995 |
| Received | Jun 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952596
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.