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U.S. Department of Health and Human Services

510(k) Premarket Notification

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161 to 170 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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easystat 300 Medica corporation K220396 09/26/2023
advia centaur® nt-probnpii (pbnpii) Siemens Healthcare Diagnostics, Inc. K220265 09/24/2023
access cea Beckman Coulter, Inc K223921 09/22/2023
alfis vitamin d, alfis-3 analyzer Immunostics Inc. K221817 09/22/2023
ilet® dosing decision software Beta Bionics, Inc. K232224 09/22/2023
architect hsv-1 igg, architect hsv-1 igg calibrator, architect hsv-1 igg controls Biokit, S.A. K213987 09/20/2023
cholestech ldx ™ system Alere San Diego, Inc. K223179 09/20/2023
ai100 with shonit SigTuple Technologies Pvt. Ltd. K221309 09/19/2023
access myoglobin Beckman Coulter, Inc K231832 09/18/2023
b·r·a·h·m·s cga ii kryptor, b·r·a·h·m·s cga ii kryptor cal, b·r·a·h·m·s cga ii kryptor qc B.R.A.H.M.S GmbH part of Thermo Fisher K222251 09/18/2023

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