FDA 510(k) Applications Submitted by DIASORIN INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K141463 |
06/03/2014 |
LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS |
DiaSorin Inc. |
| K213858 |
12/10/2021 |
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus |
DiaSorin Inc. |
| K150375 |
02/13/2015 |
LIAISON VZV IgG, LIAISON Control VZV IgG |
DiaSorin Inc. |
| K160650 |
03/08/2016 |
LIAISON HAV IgM, LIAISON Control HAV IgM |
DiaSorin Inc. |
| K150879 |
04/01/2015 |
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers |
DiaSorin Inc. |
| K161522 |
06/02/2016 |
LIAISON EBV IgM Serum Control Set |
DiaSorin Inc. |
| K161526 |
06/02/2016 |
LIAISON CMV IgM Serum Control Set |
DiaSorin Inc. |
| K201908 |
07/09/2020 |
LIAISON Testosterone xt |
DiaSorin Inc. |
| K162959 |
10/24/2016 |
LIAISON« EA IgG and LIAISON« EA IgG Serum Control Set |
DIASORIN INC. |
| K162961 |
10/24/2016 |
LIAISON« VCA IgG and LIAISON« VCA IgG Serum Control Set; LIAISON« EBNA IgG and LIAISON« EBNA IgG Serum Control Set |
DIASORIN INC. |
| K162969 |
10/24/2016 |
LIAISON« CMV IgG and LIAISON« CMV IgG Serum Control Set |
DiaSorin Inc. |
| K202573 |
09/04/2020 |
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus |
DiaSorin Inc. |
| K202574 |
09/04/2020 |
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus |
DiaSorin Inc. |
| K173683 |
12/01/2017 |
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers |
DiaSorin Inc. |
| K210272 |
02/01/2021 |
LIAISON Anti-HAV |
DiaSorin Inc. |
| K181464 |
06/04/2018 |
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set |
DiaSorin Inc. |
| K192046 |
07/31/2019 |
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set |
DiaSorin Inc. |
| K192064 |
08/01/2019 |
LIAISON Vitamin B12 |
DiaSorin Inc. |
| K192586 |
09/19/2019 |
LIAISON« Folate |
Diasorin Inc. |
| K182698 |
09/27/2018 |
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device |
DiaSorin Inc. |
| K193051 |
11/01/2019 |
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set |
DiaSorin Inc. |
| K213936 |
12/16/2021 |
LIAISON MeMed BV, LIAISON MeMed BV Control Set |
DiaSorin Inc. |
| K193532 |
12/20/2019 |
LIAISON Anti-HAV Assay |
DiaSorin Inc. |
| K231214 |
04/28/2023 |
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT |
DiaSorin Inc. |
| K223403 |
11/09/2022 |
LIAISON Anti-HAV; LIAISON XS |
DiaSorin Inc. |
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