The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Cannabinoid Urine Controls.
| Device ID | K932113 |
| 510k Number | K932113 |
| Device Name: | CANNABINOID URINE CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-03 |
| Decision Date | 1993-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011441 | K932113 | 000 |
| 00380740005672 | K932113 | 000 |
| 00380740005665 | K932113 | 000 |
| 00380740005658 | K932113 | 000 |
| 00380740005641 | K932113 | 000 |