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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 K871664
Device Name IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR
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 Received04/28/1987
Decision Date 05/08/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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