Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
152
Total
151
Cleared
1
Denied
95 devices
Cleared
Jul 13, 2018
Dimension Hemoglobin A1c Assay
Chemistry
203d
Cleared
Jul 12, 2018
ADVIA Centaur High-Sensitivity Troponin I (TNIH)
Chemistry
437d
Cleared
May 25, 2018
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
Chemistry
31d
Cleared
Apr 12, 2018
Atellica IM Folate Assay
Chemistry
265d
Cleared
Mar 29, 2018
Atellica IM Total hCG (ThCG)
Chemistry
240d
Cleared
Dec 04, 2017
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Chemistry
173d
Cleared
May 23, 2017
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
Chemistry
151d
Cleared
Mar 09, 2017
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
Chemistry
59d
Cleared
Jan 19, 2017
Atellica CH Magnesium (Mg)
Chemistry
146d
Cleared
Nov 15, 2016
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
Chemistry
167d
Cleared
Sep 07, 2016
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3...
Chemistry
175d
Cleared
Jun 29, 2016
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)...
Chemistry
348d
Cleared
May 31, 2016
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
Chemistry
85d
Cleared
Feb 11, 2016
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension...
Chemistry
248d
Cleared
Dec 18, 2015
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
Chemistry
28d
Cleared
Dec 11, 2015
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT...
Chemistry
164d
Cleared
Nov 20, 2015
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH...
Chemistry
142d
Cleared
Jul 17, 2015
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA...
Chemistry
205d
Cleared
May 01, 2015
ADVIA Centaur TSH3-Ultra
Chemistry
72d
Cleared
Apr 22, 2015
ADVIA CENTAUR TSH
Chemistry
273d
Cleared
Mar 31, 2015
ADVIA Centaur Cortisol (COR) Assy
Chemistry
189d
Cleared
Feb 26, 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000...
Chemistry
93d
Cleared
Feb 25, 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE...
Chemistry
65d
Cleared
Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000...
Chemistry
35d
Cleared
Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol...
Chemistry
29d
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