The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Thc Urine Calibrators.
| Device ID | K923386 |
| 510k Number | K923386 |
| Device Name: | THC URINE CALIBRATORS |
| Classification | Calibrators, Drug Specific |
| 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 | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1992-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740005672 | K923386 | 000 |
| 00380740005665 | K923386 | 000 |
| 00380740005658 | K923386 | 000 |
| 00380740005641 | K923386 | 000 |
| 00380740005634 | K923386 | 000 |
| 00380740005627 | K923386 | 000 |
| 00380740005610 | K923386 | 000 |
| 00380740005603 | K923386 | 000 |