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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K010403
Device Name PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
Original Applicant
HOME DIAGNOSTICS, INC.
24oo n.w. 55th ct.
fort lauderdale,  FL  33309
Original Contact karen devincent
Regulation Number862.1345
Classification Product Code
NBW  
Date Received02/12/2001
Decision Date 03/26/2001
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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