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Siemens Healthcare Diagnostics Products GmbH

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories7
Latest FDA decision2024-10-10
TypeNumberDevice NameCodeDateActions
510(k) K240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)QLU2024-10-10 View
510(k) K233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)CFN2023-12-13 View
510(k) K220728 vWF AgGGP2023-06-02 View
510(k) K212559 CardioPhase® hsCRPNQD2022-12-16 View
510(k) K212379 N Latex FLC kappa, N Latex FLC lambdaDFH2022-03-02 View
510(k) K201496 N Latex FLC kappa, N Latex FLC lambdaDFH2021-10-29 View
510(k) K193047 N Latex FLC kappa, N Latex FLC lambdaDFH2021-07-14 View
510(k) K190879 N Latex FLC kappa, N Latex FLC lambdaDFH2019-05-03 View
510(k) K182098 N Latex FLC kappa assay, N Latex FLC lambda assayDFH2018-11-01 View
510(k) K181525 INNOVANCE Free PS AgGGP2018-09-07 View
510(k) K171742 N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2DFH2017-11-17 View
510(k) K172333 Sysmex CS-5100JPA2017-10-31 View
510(k) K171072 N Latex Cystatin C; N Protein Standard UYNDY2017-05-12 View
510(k) K162688 Sysmex CS-2100iJPA2016-12-26 View
510(k) K162420 Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-12-12 View
510(k) K161317 Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-09-02 View
510(k) K161312 Sysmex Automated Blood Coagulation Analyzer CS-2100iJPA2016-09-01 View
510(k) K151259 Sysmex Automated Blood Coagulation Analyzer CS-2100iJPA2016-01-26 View
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