The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Urine Calibrators And Controls Modification.
| Device ID | K935101 |
| 510k Number | K935101 |
| Device Name: | URINE CALIBRATORS AND CONTROLS MODIFICATION |
| Classification | Calibrators, Drug Mixture |
| Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1994-01-27 |