510(k) K935568 ยท DLZ Enzyme Immunoassay, Phenobarbital
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
| Applicant | Baxter Diagnostics, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Mar 11, 1994 |
| Received | Nov 18, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935568
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.