510(k) K850856 ยท KLS Enzyme Immunoassay, Theophylline
ICS THEOPHYLLINE REAGENTS
| Applicant | Beckman Instruments, Inc., Fullerton CA, US |
| Decision | Substantially Equivalent, Mar 29, 1985 |
| Received | Mar 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850856
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.