510(k) K860464 ยท KLS Enzyme Immunoassay, Theophylline
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 17, 1986 |
| Received | Feb 6, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860464
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.