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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 5 of 5 Results
ProductCode: MMI Applicant: SIEMENS HEALTHCARE DIAGNOSTICS Decision Date To: 05/05/2024
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dimension exl high-sensitivity troponin i (tnih) assay Siemens Healthcare Diagnostics, Inc. K190675 05/17/2019
dimension vista high-sensitivity troponin i (tnih) assay Siemens Healthcare Diagnostics, Inc. K182225 03/04/2019
atellica im high-sensitivity troponin i (tnih) Siemens Healthcare Diagnostics Inc. K171566 07/19/2018
advia centaur high-sensitivity troponin i (tnih) Siemens Healthcare Diagnostics Inc. K171274 07/12/2018
dimension tni flex reagent cartridge, and ctni sample diluent with models, rf621, kd692 SIEMENS HEALTHCARE DIAGNOSTICS K081643 07/03/2008
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