Siemens Healthcare Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL), ADVIA 2120i, ADVIA 2120, LOCI Total Vitamin D Total Assay, LOCI VITD CAL
92
Total
92
Cleared
0
Denied
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostics Chemistry ✕
54 devices
Cleared
Apr 25, 2025
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
Chemistry
158d
Cleared
Mar 16, 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
Chemistry
212d
Cleared
Mar 09, 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-,...
Chemistry
234d
Cleared
Nov 17, 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)...
Chemistry
66d
Cleared
Sep 18, 2015
Dimension Vista MMB Assay
Chemistry
263d
Cleared
Jun 15, 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista...
Chemistry
441d
Cleared
Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
Chemistry
82d
Cleared
Nov 17, 2014
CLINITEK NOVUS
Chemistry
242d
Cleared
Jan 02, 2014
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM...
Chemistry
48d
Cleared
Apr 19, 2013
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
Chemistry
241d
Cleared
Apr 05, 2013
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
Chemistry
22d
Cleared
Mar 21, 2013
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
Chemistry
258d
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