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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K844585
Device Name REFERRIL CALIBRATORS
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 Number862.1150
Classification Product Code
JIX  
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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