510(k) K885253 ยท KLS Enzyme Immunoassay, Theophylline
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Mar 31, 1989 |
| Received | Dec 23, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885253
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.