FDA 510(k) Applications Submitted by Siemens Healthcare Diagnostics Products GmbH

FDA 510(k) Number Submission Date Device Name Applicant
K190879 04/04/2019 N Latex FLC kappa, N Latex FLC lambda Siemens Healthcare Diagnostics Products GmbH
K171072 04/10/2017 N Latex Cystatin C; N Protein Standard UY Siemens Healthcare Diagnostics Products GmbH
K201496 06/05/2020 N Latex FLC kappa, N Latex FLC lambda Siemens Healthcare Diagnostics Products GmbH
K171742 06/12/2017 N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 Siemens Healthcare Diagnostics Products GmbH
K182098 08/03/2018 N Latex FLC kappa assay, N Latex FLC lambda assay Siemens Healthcare Diagnostics Products GmbH
K193047 11/01/2019 N Latex FLC kappa, N Latex FLC lambda Siemens Healthcare Diagnostics Products GmbH
K172333 08/02/2017 Sysmex CS-5100 Siemens Healthcare Diagnostics Products GmbH
K162688 09/27/2016 Sysmex CS-2100i Siemens Healthcare Diagnostics Products GmbH
K212379 08/02/2021 N Latex FLC kappa, N Latex FLC lambda Siemens Healthcare Diagnostics Products GmbH
K212559 08/13/2021 CardioPhase« hsCRP Siemens Healthcare Diagnostics Products GmbH
K161312 05/10/2016 Sysmex Automated Blood Coagulation Analyzer CS-2100i SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
K161317 05/11/2016 Sysmex Automated Blood Coagulation Analyzer CS-5100 Siemens Healthcare Diagnostics Products GmbH
K151259 05/12/2015 Sysmex Automated Blood Coagulation Analyzer CS-2100i SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
K220728 03/14/2022 vWF Ag Siemens Healthcare Diagnostics Products GmbH
K181525 06/11/2018 INNOVANCE Free PS Ag Siemens Healthcare Diagnostics Products GmbH
K162420 08/30/2016 Sysmex Automated Blood Coagulation Analyzer CS-5100 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
DEN200067 10/28/2020 INNOVANCE VWF Ac Siemens Healthcare Diagnostics Products GmbH


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