|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
atellica® ci analyzer, atellica® imthyroid stimulating hormone 3-ultra (tsh3-ul), atellica® ch albumin bcp (albp)
|
Siemens Healthcare Diagnostics Inc.
|
K222116 |
07/13/2023
|
atellica solution, atellica a-lyte integrated multisensor na+/k+/ci-, atellica ch albumin bcp reagent (alb_p), atellica im thyroid stimulating hormone tsh, atellica ch vancomycin (vanc)
|
Siemens Healthcare Diagnostics
|
K161954 |
03/09/2017
|
immulite 2000 third generation tsh, immulite 2000 free t4
|
Siemens Healthcare Diagnostics Inc.
|
K160647 |
05/31/2016
|
trinidad im thyroid stimulating hormone (tsh) assay, trinidad im tsh calibrators, trinidad immunoassay (im) system
|
Siemens Healthcare Diagnostics,Inc.
|
K151792 |
11/20/2015
|
advia centaur tsh3-ultra
|
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
|
K150403 |
05/01/2015
|
advia centaur tsh
|
Siemens Healthcare Diagnostics Inc.
|
K141999 |
04/22/2015
|
dimension loci free thyroxine flex reagent cartridge, ft4l, dimension loci thyroid stimulating hormone flex reagent cart
|
Siemens Healthcare Diagnostics Inc.
|
K140842 |
11/26/2014
|
dimension vista free thyroxine flex reagent cartridge, ft4, dimension vista thyroid stimulating hormone flex reagent
|
Siemens Healthcare Diagnostics Inc.
|
K140859 |
11/26/2014
|
advia centaur tsh3-ultra method
|
SIEMENS HEALTHCARE DIAGNOSTICS
|
K083844 |
05/08/2009
|
dimension tshl flex reagent cartridge and tsh sample diluent with models rf 612 and kd691
|
Siemens Healthcare Diagnostics Inc.
|
K081074 |
05/23/2008
|