Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
152
Total
151
Cleared
1
Denied
152 devices
Cleared
Aug 31, 2017
Atellica IM Ferritin Assay
Immunology
90d
Cleared
May 23, 2017
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
Chemistry
151d
Cleared
Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
Toxicology
141d
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
Oct 13, 2016
ADVIA Centaur HAV IgM Assay
Microbiology
87d
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
Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
Toxicology
90d
Cleared
Mar 03, 2016
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
Immunology
223d
Cleared
Feb 11, 2016
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension...
Chemistry
248d
Cleared
Dec 22, 2015
ADVIA Centaur Toxoplasma M (Toxo M)
Microbiology
448d
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
Oct 23, 2015
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug...
Toxicology
227d
Cleared
Jul 17, 2015
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA...
Chemistry
205d
Cleared
Jul 02, 2015
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
Microbiology
174d
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
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