The following data is part of a premarket notification filed by U.s. Drug Testing, Inc. with the FDA for Usdt Opiate Assay Column Catalog No. 9000-200.
| Device ID | K932318 |
| 510k Number | K932318 |
| Device Name: | USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-11 |
| Decision Date | 1993-06-15 |