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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Micro, For Clinical Use
510(k) Number K851933
Device Name CLINICAL CHEMISTRY ANALYTICAL SYSTEM
Applicant
Allied Instrumentation Laboratory
113 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact GEORGE A LYNA
Correspondent
Allied Instrumentation Laboratory
113 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact GEORGE A LYNA
Regulation Number862.2170
Classification Product Code
JJF  
Date Received05/02/1985
Decision Date 06/10/1985
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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