FDA 510(k) Applications Submitted by Siemens Healthcare Diagnostics, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K220262 01/31/2022 Dimension EXL LOCI BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics, Inc.
K192777 09/30/2019 ADVIA Centaur CA 15-3 assay Siemens Healthcare Diagnostics, Inc.
K193397 12/06/2019 ADVIA Centaur« Digoxin assay Siemens Healthcare Diagnostics, Inc.
K220265 01/31/2022 ADVIA Centaur« NT-proBNPII (PBNPII) Siemens Healthcare Diagnostics, Inc.
K140258 02/03/2014 IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K142878 10/02/2014 IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143373 11/25/2014 IMMULITE« 2000 Calcitonin Calibration Verification Material , IMMULITE« 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143636 12/22/2014 IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K123933 12/20/2012 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K200199 01/27/2020 ADVIA Centaur CA 125II Siemens Healthcare Diagnostics, Inc.
K142864 10/01/2014 ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143194 11/06/2014 ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143376 11/25/2014 ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143687 12/24/2014 ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143680 12/24/2014 ADVIA Centaur IgE Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K150606 03/10/2015 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K132739 09/03/2013 IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K192788 09/30/2019 ADVIA Centaur Cortisol (COR) Siemens Healthcare Diagnostics, Inc.
K111677 06/15/2011 MICROSCAN(R) MICROSTREP PLUS(R) SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K170065 01/09/2017 ADVIA« Chemistry Total Bilirubin_2 (TBIL_2) Siemens Healthcare Diagnostics, Inc.
K200256 02/03/2020 ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay Siemens Healthcare Diagnostics, Inc.
K221605 06/02/2022 Emit« II Plus Buprenorphine Assay Siemens Healthcare Diagnostics, Inc.
K151529 06/08/2015 Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K160724 03/16/2016 ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K181082 04/24/2018 ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) Siemens Healthcare Diagnostics, Inc.
K131307 05/07/2013 ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K181213 05/07/2018 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control Siemens Healthcare Diagnostics, Inc.
K112343 08/15/2011 TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K132664 08/27/2013 ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K133067 09/27/2013 ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K153365 11/20/2015 ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K103701 12/20/2010 ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K160202 01/28/2016 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K190675 03/15/2019 Dimension EXL High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc.
K161494 06/01/2016 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) Siemens Healthcare Diagnostics, Inc.
K151767 06/30/2015 Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K182225 08/16/2018 Dimension Vista High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc.
K162399 08/26/2016 Atellica CH Magnesium (Mg) SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K163220 11/16/2016 Atellica CH Phencyclidine (Pcp) Siemens Healthcare Diagnostics, Inc.
K192240 08/19/2019 RAPIDPoint 500e Blood Gas System Siemens Healthcare Diagnostics, Inc.
K150403 02/18/2015 ADVIA Centaur TSH3-Ultra SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K142826 09/30/2014 ADVIA Centaur Toxoplasma M (Toxo M) SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K200210 01/28/2020 ADVIA Centaur« Total hCG assay Siemens Healthcare Diagnostics, Inc.
K110874 03/29/2011 ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K130276 02/05/2013 DIMENSION EXL WITH LM SYSTEM SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K161964 07/18/2016 ADVIA Centaur HAV IgM Assay Siemens Healthcare Diagnostics, Inc.
K142758 09/25/2014 ADVIA Centaur HAV total assay SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K143352 11/24/2014 IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K111205 04/29/2011 MICROSCAN (R) MICROSTREP PLUS (R) PANELS SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K152061 07/24/2015 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC.


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