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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
24oo n.w. 55th ct.
fort lauderdale,  FL  33309
Original Contact karen devincent
Regulation Number862.1345
Classification Product Code
Date Received02/12/2001
Decision Date 03/26/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No