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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 K844586
Device Name IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Applicant Contact GEORGE A LYNA
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Correspondent Contact GEORGE A LYNA
Regulation Number862.2170
Classification Product Code
JJF  
Date Received11/23/1984
Decision Date 12/11/1984
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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