The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for 50ng/ml Cocaine Metabolite Calibrator.
| Device ID | K972835 |
| 510k Number | K972835 |
| Device Name: | 50NG/ML COCAINE METABOLITE CALIBRATOR |
| Classification | Calibrators, Drug Specific |
| Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-31 |
| Decision Date | 1997-08-28 |