510(k) K971361 ยท DJG Enzyme Immunoassay, Opiates
AQ OPIATES (MORPHINE) TEST
| Applicant | Bionike Laboratories, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Jun 6, 1997 |
| Received | Apr 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971361
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.