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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 
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23andme personal genome service (pgs) pharmacogenetic reports 23andMe, Inc. K193492 08/17/2020
23andme personal genome service (pgs) pharmacogenetic reports 23andMe, Inc. K221885 10/26/2022
23andme pgs genetic risk report for hereditary prostate cancer (hoxb13-related) 23andMe, Inc. K211499 01/06/2022
23andme® personal genome service® (pgs®) cancer predisposition genetic health risk report for brca1/brca2 (selected variants) 23andMe, Inc. K223597 08/31/2023
mutyh-associated polyposis (map) 23andMe, Inc. K182784 01/18/2019
audit microcontrols linearity fd tumor markers ii AALTO SCIENTIFIC LTD. K143573 01/16/2015
audit microcontrols linearity fd unsaturated iron binding capacity AALTO SCIENTIFIC LTD. K143026 11/21/2014
audit microcontrols linearity lq special diabetes AALTO SCIENTIFIC LTD. K142978 11/20/2014
audit microcontrols microfd bnp control AALTO SCIENTIFIC LTD. K032122 09/09/2003
audit microcv ammonian/ethanol linearity set, model k712m-5 AALTO SCIENTIFIC LTD. K100718 09/03/2010

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