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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 K933557
Device Name REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE
Applicant
Consolidated Technologies, Inc.
2170 Woodward St., Suite 100
Austin,  TX  78744
Applicant Contact E. KAY ROBINSON
Correspondent
Consolidated Technologies, Inc.
2170 Woodward St., Suite 100
Austin,  TX  78744
Correspondent Contact E. KAY ROBINSON
Regulation Number862.3280
Classification Product Code
LAS  
Date Received07/21/1993
Decision Date 09/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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