510(k) K180879 ยท DKZ Enzyme Immunoassay, Amphetamine
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
| Applicant | Shanghai Venture Bio-Tech Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Dec 14, 2018 |
| Received | Apr 3, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180879
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.