The following data is part of a premarket notification filed by U.s. Drug Testing, Inc. with the FDA for Amphetamine Test System.
Device ID | K934693 |
510k Number | K934693 |
Device Name: | AMPHETAMINE TEST SYSTEM |
Classification | Enzyme Immunoassay, Amphetamine |
Applicant | U.S. DRUG TESTING, INC. 10410 TRADEMARK ST. Rancho Cucamonga, CA 91730 |
Contact | Clifford Bennett |
Correspondent | Clifford Bennett U.S. DRUG TESTING, INC. 10410 TRADEMARK ST. Rancho Cucamonga, CA 91730 |
Product Code | DKZ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-30 |
Decision Date | 1993-11-22 |