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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
Recalls CDRH Recalls
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