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 |