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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