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U.S. Department of Health and Human Services

510(k) Premarket Notification
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151 to 160 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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miris human milk analyzer (hma) Miris AB K223085 09/29/2023
stat profile prime plus analyzer system Nova Biomedical Corporation K221900 09/29/2023
tbi Abbott Laboratories K232669 09/29/2023
ultraflo-r push button blood collection set Innovative Medical Technologies, Inc. K220458 09/29/2023
dna/rna shield safecollect saliva collection kit Zymo Research K231013 09/28/2023
pivo™ pro needle-free blood collection device Becton Dickinson Infusion Therapy Systems, Inc. K230865 09/28/2023
afinion™ hba1c, afinion™ 2 and alere afinion™ as100 analyzer Abbott Diagnostics Technologies AS K214117 09/27/2023
cedia heroin metabolite (6-am) assay Microgenics Corporation K231007 09/27/2023
xpert® xpress gbs, genexpert® dx system, genexpert® infinity systems Cepheid K222638 09/27/2023
access thyroglobulin antibody ii Beckman Coulter, Inc. K213517 09/26/2023

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