The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Urine Calibrator.
| Device ID | K940935 |
| 510k Number | K940935 |
| Device Name: | URINE CALIBRATOR |
| Classification | Calibrators, Drug Mixture |
| Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Contact | Yuh-geng Tsay, Ph.d |
| Correspondent | Yuh-geng Tsay, Ph.d 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 | 1994-02-25 |
| Decision Date | 1994-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740005474 | K940935 | 000 |
| 00380740005467 | K940935 | 000 |
| 00380740005450 | K940935 | 000 |
| 00380740005443 | K940935 | 000 |
| 00884883005044 | K940935 | 000 |