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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 13 Results
ProductCode: JIT Applicant: SIEMENS HEALTHCARE DIAGNOSTICS INC Decision Date To: 05/06/2024
 
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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 SIEMENS HEALTHCARE DIAGNOSTICS INC. K151986 06/29/2016
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
advia chemistry myoglobin reagent, advia chemistry myoglbin calibrator Siemens Healthcare Diagnostics Inc. K122599 10/03/2012
dimension vista loci 9 calibrator- loci 9 cal Siemens Healthcare Diagnostics Inc. K113373 12/30/2011
advia centaur calibarator 80 model 10492491 Siemens Healthcare Diagnostics Inc. K103548 06/02/2011
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
enzyme ii calibrator SIEMENS HEALTHCARE DIAGNOSTICS INC K103836 02/16/2011
dimension vista enzymatic creatinine flex reagent cartridge, and enzymatic creatinine calibrator, models k1270, kc270 Siemens Healthcare Diagnostics Inc. K090330 05/22/2009
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