510(k) K980349 ยท DIS Enzyme Immunoassay, Barbiturate
QUICKPAC II ONE STEP BARBITURATE TEST
| Applicant | Syntron Bioresearch, Inc., Simi Valley CA, US |
| Decision | Substantially Equivalent, Mar 3, 1998 |
| Received | Jan 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980349
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.