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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 K914909
Device Name IL TEST(TM) CALIBRATION SET SP
Original Applicant
INSTRUMENTATION LABORATORY CO.
113 hartwell ave.
p.o. box 9113
lexington,  MA  02173
Original Contact george a lyna
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/01/1991
Decision Date 01/22/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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