510(k) K942192 ยท LER Fluorescent Immunoassay, Theophylline
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jul 13, 1994 |
| Received | May 4, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942192
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.