510(k) K953016 ยท LGS Fluorescence Polarization Immunoassay, Theophylline
AXSYM THEOPHYLLINE II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 24, 1995 |
| Received | Jun 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953016
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.