510(k) K915755 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
BIOTRACK PHENYTOIN TEST CARTRIDGE
| Applicant | Biotrack, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jul 23, 1992 |
| Received | Dec 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915755
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.