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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 K862420
Device Name UTAK-STABBS 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 Number862.1660
Classification Product Code
JJY  
Date Received06/25/1986
Decision Date 08/04/1986
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
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