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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 6 of 6 Results
ProductCode: LCP Applicant: SIEMENS HEALTHCARE DIAGNOSTICS Decision Date To: 05/01/2024
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advia chemistry enzymatic hemoglobin ale (alc_e) assay Siemens Healthcare Diagnostics, Inc. K200256 07/02/2021
dimension hemoglobin a1c assay Siemens Healthcare Diagnostics Inc. K173909 07/13/2018
advia chemistry enzymatic hemoglobin a1c (a1c_e) assay Siemens Healthcare Diagnostics Inc. K171771 12/04/2017
advia chemistry fructosamine assay, advia chemistry fructosamine calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. K131307 01/24/2014
advia chemistry hemoglobin a1c_3 (a1c_3) automated pretreatment assay SIEMENS HEALTHCARE DIAGNOSTICS K110934 08/25/2011
dimensions hb1c kit, model df105a SIEMENS HEALTHCARE DIAGNOSTICS K102510 05/13/2011
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