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FDA 510(k) Applications Submitted by Asha Gartland
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150132
01/21/2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
Siemens Healthcare Diagnostics
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.
K141772
07/01/2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
Siemens Healthcare Diagnostics Inc.
K142811
09/29/2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
Siemens Healthcare Diagnostics Inc.
K133128
09/30/2013
IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION
Siemens Healthcare Diagnostics Inc.
K143639
12/22/2014
IMMULITE 2000 CEA Calibration Verification Material
Siemens Healthcare Diagnostics
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