The following data is part of a premarket notification filed by U.s. Drug Testing, Inc. with the FDA for Usdt Phencyclidine (pcp) Assay Column Cat. No. 9000-400.
| Device ID | K935629 |
| 510k Number | K935629 |
| Device Name: | USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 |
| Classification | Enzyme Immunoassay, Phencyclidine |
| 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 | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-23 |
| Decision Date | 1994-04-12 |