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FDA 510(k) Applications Submitted by DONNA VELASQUEZ
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100910
04/01/2010
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
K141444
06/02/2014
IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
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.
K093987
12/24/2009
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
Siemens Healthcare Diagnostics Inc.
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