FDA 510(k) Applications Submitted by Fatima Pacheco

FDA 510(k) Number Submission Date Device Name Applicant
K140267 02/03/2014 ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) Siemens Healthcare Diagnostics Inc.
K140505 02/27/2014 ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL Siemens Healthcare Diagnostics Inc.
K181002 04/16/2018 Atellica IM BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics Inc.
K142723 09/23/2014 ADVIA Centaur Cortisol (COR) Assy 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.
K143680 12/24/2014 ADVIA Centaur IgE 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.


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