510(k) K153474 ยท DIF Drug Mixture Control Materials
Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
| Applicant | Biochemical Diagnostics, Inc., Edgewood NY, US |
| Decision | Substantially Equivalent, Feb 23, 2016 |
| Received | Dec 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153474
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.