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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K883147
Device Name TRACE ELEMENTS SERUM TOXICOLOGY CONTROL
Applicant
UTAK LABORATORIES, INC.
26752OAK AVENUE, SUITE J
CANYON COUNTRY,  CA  91351 -2409
Applicant Contact LAWRENCE B PLUTCHAK
Correspondent
UTAK LABORATORIES, INC.
26752OAK AVENUE, SUITE J
CANYON COUNTRY,  CA  91351 -2409
Correspondent Contact LAWRENCE B PLUTCHAK
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/26/1988
Decision Date 10/06/1988
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
Recalls CDRH Recalls
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