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U.S. Department of Health and Human Services

510(k) Premarket Notification
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21 to 30 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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a1c ez glycohemoglobin analysis system BioHermes Co., Ltd K161533 06/16/2017
a1c gear system Sakae Corporation K130014 04/04/2014
a1c igear system Sakae Corporation K142789 12/16/2014
a1c-cellular STRECK LABORATORIES, INC. K040025 03/02/2004
a1cnow for home and professional use METRIKA, INC. K033847 12/23/2003
a1cnow+ (10 test kit, professional use) model 3024, a1cnow+(20 test kit, professional use) model 3021, a1cnow self chec BAYER HEALTHCARE, LLC K090413 05/14/2009
ab-trol and private label glucose control solution FUJIREBIO DIAGNOSTICS TEXAS, INC. K080273 08/08/2008
abacus 3cp DIATRON US INC K111534 08/02/2012
abacus 5 DIATRON US INC K112755 03/27/2012
abbott architect estradiol calibrators; abbott imx estradiol calibrator; abbott imx estradiol mode 1 calibrator; abbott ABBOTT LABORATORIES K032458 10/06/2003

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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