The following data is part of a premarket notification filed by Biochemical Diagnostic, Inc. with the FDA for Detectabuse(tm).
| Device ID | K925586 |
| 510k Number | K925586 |
| Device Name: | DETECTABUSE(TM) |
| Classification | Drug Mixture Control Materials |
| Applicant | BIOCHEMICAL DIAGNOSTIC, INC. 180 HEARTLAND BLVD. Brentwood, NY 11717 |
| Contact | Allen Panetz |
| Correspondent | Allen Panetz BIOCHEMICAL DIAGNOSTIC, INC. 180 HEARTLAND BLVD. Brentwood, 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 | 1992-11-04 |
| Decision Date | 1992-12-28 |