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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K932113
Device Name CANNABINOID URINE CONTROLS
Applicant
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Correspondent Contact YUH-GENG TSAY
Regulation Number862.1660
Classification Product Code
JJX  
Date Received05/03/1993
Decision Date 06/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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