510(k) K061617 ยท DKZ Enzyme Immunoassay, Amphetamine
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
| Applicant | Tianjin New Bay Bioresearch Co., Ltd., Carlsbad CA, US |
| Decision | Substantially Equivalent, Nov 22, 2006 |
| Received | Jun 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061617
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.