Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
152
Total
151
Cleared
1
Denied
152 devices
Cleared
Jul 02, 2021
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
Chemistry
515d
Cleared
May 29, 2020
ADVIA Centaur Vitamin D Total (VitD)
Chemistry
88d
Cleared
Apr 06, 2020
ADVIA Centaur CA 125II
Immunology
70d
Cleared
Mar 27, 2020
RAPIDPoint 500e Blood Gas System
Chemistry
221d
Cleared
Feb 13, 2020
ADVIA Centaur BR
Immunology
58d
Cleared
Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
Immunology
29d
Cleared
Nov 25, 2019
ADVIA Centaur Cortisol (COR)
Chemistry
56d
Cleared
Nov 22, 2019
ADVIA Centaur CA 15-3 assay
Immunology
53d
Cleared
Oct 30, 2019
Atellica IM Total hCG (ThCG)
Chemistry
30d
Cleared
Aug 28, 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
Chemistry
79d
Cleared
Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
Chemistry
60d
Cleared
Jul 17, 2019
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur...
Microbiology
33d
Cleared
May 17, 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
Chemistry
63d
Cleared
Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
Chemistry
200d
Cleared
Jul 30, 2018
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
Microbiology
84d
Cleared
Jul 19, 2018
Atellica IM High-Sensitivity Troponin I (TNIH)
Chemistry
415d
Cleared
Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
Microbiology
91d
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
Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
Toxicology
267d
Cleared
Oct 18, 2017
Emit II Plus Oxycodone Assay
Toxicology
23d
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