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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K943422
Device Name TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL
Applicant
Utak Lab, Inc.
25020 Ave. Tibbitts
Valencia,  CA  91355
Applicant Contact LAWRENCE PLUTCHAK
Correspondent
Utak Lab, Inc.
25020 Ave. Tibbitts
Valencia,  CA  91355
Correspondent Contact LAWRENCE PLUTCHAK
Regulation Number862.3280
Classification Product Code
DIF  
Date Received07/15/1994
Decision Date 11/02/1994
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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