The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Phenytoin Calibrators.
| Device ID | K945337 |
| 510k Number | K945337 |
| Device Name: | PHENYTOIN CALIBRATORS |
| Classification | Calibrators, Drug Specific |
| Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Contact | Yug-gen Tsay |
| Correspondent | Yug-gen Tsay DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1994-12-07 |