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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 K843986
Device Name STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3
Applicant
United Diagnostics, Inc.
8 Tech Cir.
Natick,  MA  01760
Applicant Contact NORMAN KLEINMAN
Correspondent
United Diagnostics, Inc.
8 Tech Cir.
Natick,  MA  01760
Correspondent Contact NORMAN KLEINMAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/11/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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