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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 K903061
Device Name UTAK LABORATORIES TOXICOLOGY CONTROL
Applicant
Utak Laboratories, Inc.
26752 Oak Ave. # 5
Canyon Country,  CA  91351
Applicant Contact LAWRENCE B PLUTCHAK
Correspondent
Utak Laboratories, Inc.
26752 Oak Ave. # 5
Canyon Country,  CA  91351
Correspondent Contact LAWRENCE B PLUTCHAK
Regulation Number862.3280
Classification Product Code
LAS  
Date Received07/09/1990
Decision Date 04/12/1991
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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