The following data is part of a premarket notification filed by U.s. Drug Testing, Inc. with the FDA for Usdt Cannabinoid (thc) Assay Column Catalog No. 9000-500.
Device ID | K940912 |
510k Number | K940912 |
Device Name: | USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 |
Classification | Enzyme Immunoassay, Cannabinoids |
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 | LDJ |
CFR Regulation Number | 862.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-25 |
Decision Date | 1994-06-02 |