The following data is part of a premarket notification filed by U.s. Drug Testing, Inc. with the FDA for Usdt Flow Immunoassay System, Model 9000.
| Device ID | K931227 |
| 510k Number | K931227 |
| Device Name: | USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 |
| Classification | Chromatography (liquid, Gel), Clinical Use |
| 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 | KZR |
| CFR Regulation Number | 862.2260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-10 |
| Decision Date | 1993-05-06 |