The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Drugs Of Abuse Controls.
Device ID | K935285 |
510k Number | K935285 |
Device Name: | DRUGS OF ABUSE CONTROLS |
Classification | Drug Mixture Control Materials |
Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
Contact | Michael D Bick, Ph.d |
Correspondent | Michael D Bick, Ph.d MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
Product Code | DIF |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-03 |
Decision Date | 1994-03-22 |