510(k) K940267 ยท KXT Enzyme Immunoassay, Digoxin
ACE CLINICAL CHEMISTRY SYSTEM
| Applicant | Schiapparelli Biosystems, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, May 3, 1994 |
| Received | Jan 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940267
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.