510(k) K942991 ยท LGS Fluorescence Polarization Immunoassay, Theophylline
QMS THEOPHYLLINE CS
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 9, 1994 |
| Received | Jun 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942991
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.