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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 
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dna/rna shield collection tube Zymo Research K202641 12/14/2020
dna/rna shield safecollect saliva collection kit Zymo Research K231013 09/28/2023
coagcare anticoagulation management system ZYCARE K050821 08/16/2005
blood collecting needle, safety blood collecting needle, blood collecting needle with holder, safety blood collecting needle with holder, blood collecting set, safety blood collecting set, blood collecting set with holder, safety blood collecting set with holder Zhejiang Kindly Medical Devices Co.,Ltd K172763 06/04/2018
disposable urine collection tube Zhejiang Gongdong Medical Technology Co., Ltd. K220739 11/17/2022
sample preservation solution Zhejiang GENE SCIENCE Co., Ltd. K212878 04/08/2024
athena multi-lyte treponema pallidum igg plus test system ZEUS SCIENTIFIC, INC. (ZEUS) K093837 10/01/2010
athena multi-lite rheumatoid factor igm test system ZEUS SCIENTIFIC, INC. K033802 02/27/2004
athena multi-lyte ana-ii test system ZEUS SCIENTIFIC, INC. K042416 10/08/2004
athena multi-lyte borrelia vlse-1/pepc10 plus test system ZEUS SCIENTIFIC, INC. K100728 07/06/2010

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