510(k) K152551 · DJG Enzyme Immunoassay, Opiates
First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.
| Applicant | W.H.P.M., Inc., Irwindale CA, US |
| Decision | Substantially Equivalent, Nov 9, 2015 |
| Received | Sep 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152551
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.