510(k) K941489 ยท DIS Enzyme Immunoassay, Barbiturate
ACE CLINICAL CHEMISTRY SYSTEM
| Applicant | Schiapparelli Biosystems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Jul 18, 1994 |
| Received | Mar 28, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941489
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.