510(k) K882570 ยท LER Fluorescent Immunoassay, Theophylline
TURBOX THEOPHYLLINE ASSAY
| Applicant | Unipath , Ltd., Bedford Mk41 Oqg, GB |
| Decision | Substantially Equivalent, Nov 10, 1988 |
| Received | Jun 22, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882570
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.