510(k) K150606 ยท DJG Enzyme Immunoassay, Opiates
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Oct 23, 2015 |
| Received | Mar 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150606
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.