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Device Name
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Applicant
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510(K) Number
|
Decision Date
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adva centaur testosterone ii (tstii), adva centaur testosterone ii (tstii) master curve material, advia centaur shbg, advia centaur shbg calibrator, advia centaur shbg master curve material
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SIEMENS HEALTHCARE DIAGNOSTICS INC.
|
K151986 |
06/29/2016
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advia centaur vitamin d total (vitd) assay;advia centaur vitd total calibrators,quality control & master control materia
|
Siemens Healthcare Diagnostics Inc.
|
K133156 |
07/24/2014
|
immulite 2000 anti-ccp igg assay
|
Siemens Healthcare Diagnostics Inc.
|
K121576 |
04/04/2013
|
advia chemistry lipoprotein(a) reagent advia chemistry lipoprotein(a) calibrator
|
Siemens Healthcare Diagnostics Inc.
|
K123046 |
12/20/2012
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advia chemistry myoglobin reagent, advia chemistry myoglbin calibrator
|
Siemens Healthcare Diagnostics Inc.
|
K122599 |
10/03/2012
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dimension vista loci 9 calibrator- loci 9 cal
|
Siemens Healthcare Diagnostics Inc.
|
K113373 |
12/30/2011
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advia centaur calibarator 80 model 10492491
|
Siemens Healthcare Diagnostics Inc.
|
K103548 |
06/02/2011
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dimension vista loci ca 19-9 flex reagent cartridge, and dimension loci7 calibrator with model(s) k6457, and kc604
|
Siemens Healthcare Diagnostics Inc.
|
K100375 |
04/06/2011
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enzyme ii calibrator
|
SIEMENS HEALTHCARE DIAGNOSTICS INC
|
K103836 |
02/16/2011
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dimension vista enzymatic creatinine flex reagent cartridge, and enzymatic creatinine calibrator, models k1270, kc270
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Siemens Healthcare Diagnostics Inc.
|
K090330 |
05/22/2009
|