FDA 510(k) Applications Submitted by DIASORIN, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K061247 05/03/2006 DIASORIN LIAISON TREPONEMA ASSAY DIASORIN, INC.
K081685 06/17/2008 LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG DIASORIN, INC.
K081687 06/17/2008 LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG DIASORIN, INC.
K082049 07/18/2008 LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV DIASORIN, INC.
K082050 07/18/2008 LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM DIASORIN, INC.
K122397 08/07/2012 LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM DIASORIN, INC.
K132515 08/12/2013 LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DIASORIN, INC.
K062473 08/24/2006 LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 DIASORIN, INC.
K052794 10/03/2005 ETI-MAX 3000 DIASORIN, INC.
K093498 11/12/2009 LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 DIASORIN, INC.
K071480 05/29/2007 LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 DIASORIN, INC.
K032844 09/11/2003 LIAISON 25 OH VITAMIN D DIASORIN, INC.
K014030 12/06/2001 1,25-DIHYDROXYVITAMIN D125I RIA DIASORIN, INC.
K040120 01/20/2004 DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS DIASORIN, INC.
K060204 01/26/2006 LIAISON EA IGG DIASORIN, INC.
K041014 04/20/2004 TSH-CTK-3 IRMA DIASORIN, INC.
K033426 10/27/2003 LIAISON N-TACT PTH DIASORIN, INC.
K132234 07/18/2013 LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II DIASORIN, INC.
K122793 09/12/2012 LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET DIASORIN, INC.
K161139 04/22/2016 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set DIASORIN, INC.
K112725 09/20/2011 LIAISON 25 OH VITAMIN D TOTAL ASSAY DIASORIN, INC.
K001118 04/07/2000 MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DIASORIN, INC.
K991459 04/26/1999 COPALIS EBV-M ANTIBODY ASSAY DIASORIN, INC.
K991660 05/14/1999 COPALIS MULTIPLEX EBV ANTIBODY ASSAY DIASORIN, INC.
K982027 06/02/1998 MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY DIASORIN, INC.
K992191 06/28/1999 ETI-EA-G ASSAY DIASORIN, INC.
K992552 07/30/1999 COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY DIASORIN, INC.
K982708 08/04/1998 SPQ TEST SYSTEM DIASORIN, INC.
K993291 10/01/1999 COPALIS RUBELLA IGM DIASORIN, INC.
K983617 10/15/1998 25-HYDROXYVITAMIN D 125I RIA KIT DIASORIN, INC.
K993669 11/01/1999 LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DIASORIN, INC.
K983880 11/02/1998 TRANSFERRIN SPQ III ANTIBODY REAGENT SET DIASORIN, INC.
K130469 02/25/2013 LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 DIASORIN, INC.
K090104 01/15/2009 LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 DIASORIN, INC.
K121951 07/03/2012 LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 DIASORIN, INC.
K131037 04/15/2013 LIAISON XL HCG DIASORIN, INC.
K141116 04/30/2014 LIAISON XL ANALYZER DIASORIN, INC.
K061820 06/28/2006 DIASORIN LIAISON VZV IGG DIASORIN, INC.
K121944 07/03/2012 LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT DIASORIN, INC.
K132492 08/09/2013 LIAISON 25 TOTAL-D DIASORIN, INC.
K103529 12/01/2010 LIAISON XL ANALYZER MODEL 10050 DIASORIN, INC.
K073390 12/03/2007 DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS DIASORIN, INC.
K131441 05/20/2013 LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II DIASORIN, INC.


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