The following data is part of a premarket notification filed by Biochemical Diagnostic, Inc. with the FDA for Detectabuse Liquid Control, Detectabuse Stat-skreen Liquid Control.
| Device ID | K121122 |
| 510k Number | K121122 |
| Device Name: | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | BIOCHEMICAL DIAGNOSTIC, INC. 180 HEARTLAND BLVD. Edgewood, NY 11717 |
| Contact | Allen Panetz |
| Correspondent | Allen Panetz BIOCHEMICAL DIAGNOSTIC, 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 | 2012-04-13 |
| Decision Date | 2012-07-03 |