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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drug specific control materials
510(k) Number K992151
Device Name REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
Applicant
CONSOLIDATED TECHNOLOGIES, INC.
2170 WOODWARD STREET, STE. 100
AUSTIN,  TX  78744 -1832
Applicant Contact E. KAY ROBINSON
Correspondent
CONSOLIDATED TECHNOLOGIES, INC.
2170 WOODWARD STREET, STE. 100
AUSTIN,  TX  78744 -1832
Correspondent Contact E. KAY ROBINSON
Regulation Number862.3280
Classification Product Code
LAS  
Date Received06/24/1999
Decision Date 07/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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