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U.S. Department of Health and Human Services

510(K) Premarket Notification
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hp458e electrically powered wheelchair Kunshan Hi-Fortune Health Products Co., Ltd. k212503 01/18/2022
human iga liquid reagent kit for use on spaplus The Binding Site Group Ltd k192116 09/04/2019
i_space 1.5t superconducting magnetic resonance imaging system MRI Division, Beijing Wandong Medical Technology Co., Ltd. k192650 01/29/2021
il 7f flow director thermal dilu. cath INSTRUMENTATION LABORATORY CO. k820702 04/21/1982
il88640 & 88641 cassette-tape program INSTRUMENTATION LABORATORY CO. k801131 05/23/1980
iluma vision model version 2.2 3M IMTEC k094064 04/30/2010
imagechecker-ct workstation R2 TECHNOLOGY, INC. k023003 11/20/2002
imc hypodermic needle INTERNATIONAL MEDSURG CONNECTION k102584 01/14/2011
immulite 2000 beta-2 microglobulin calibration verification material, immulite 2000 high sensitivity crp calibration verification material SIEMENS HEALTHCARE DIAGNOSTICS, INC. k142878 10/30/2014
immunocap allergen f433, allergen component rtri a 14 ltp, wheat, immunocap allergen f416, allergen component rtri a 19 omega-5 gliadin, wheat, immunocap allergen f449, allergen component rses i 1 sesame seed Phadia AB k212181 08/03/2022

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