510(k) K932127 ยท LGS Fluorescence Polarization Immunoassay, Theophylline
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 9, 1993 |
| Received | May 3, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932127
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.