The following data is part of a premarket notification filed by Biochemical Diagnostics, Inc with the FDA for 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.
| Device ID | K153474 |
| 510k Number | K153474 |
| Device Name: | 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 |
| Classification | Drug Mixture Control Materials |
| Applicant | BIOCHEMICAL DIAGNOSTICS, INC 180 HEARTLAND BLVD Edgewood, NY 11717 |
| Contact | Allen Panetz |
| Correspondent | Allen Panetz BIOCHEMICAL DIAGNOSTICS, INC 180 HEARTLAND BLVD Edgewood, NY 11717 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-02 |
| Decision Date | 2016-02-23 |
| Summary: | summary |