510(k) K033659 ยท DKZ Enzyme Immunoassay, Amphetamine
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
| Applicant | Varian, Inc., Lake Forest CA, US |
| Decision | Substantially Equivalent, Jan 6, 2004 |
| Received | Nov 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033659
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.