Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DiaSorin, Inc. · Predicate Candidate Screening

71 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time

237 days90th percentile

71clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260770	LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX	DiaSorin, Inc.	2026-06-04	87	0
DEN250032	LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Contr	DiaSorin, Inc.	2025-12-23	146	0
K231214	LIAISON VZV IgG HT, LIAISON Control VZV IgG HT	DiaSorin, Inc.	2023-10-27	182	0
K223403	LIAISON Anti-HAV; LIAISON XS	DiaSorin, Inc.	2022-12-09	30	0
K213858	LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus	DiaSorin, Inc.	2022-07-26	228	1
K213936	LIAISON MeMed BV, LIAISON MeMed BV Control Set	DiaSorin, Inc.	2022-07-14	210	0
K193650	LIAISON Ferritin	DiaSorin, Inc.	2021-09-14	624	0
K202573	LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme	DiaSorin, Inc.	2021-02-18	167	0
K202574	LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme	DiaSorin, Inc.	2021-02-18	167	0
K210272	LIAISON Anti-HAV	DiaSorin, Inc.	2021-02-09	8	0
K201908	LIAISON Testosterone xt	DiaSorin, Inc.	2020-10-15	98	0
K192586	LIAISON® Folate	DiaSorin, Inc.	2020-05-06	230	0
K193532	LIAISON Anti-HAV Assay	DiaSorin, Inc.	2020-03-02	73	0
K193051	LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibod	DiaSorin, Inc.	2020-01-29	89	0
K192046	LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture I	DiaSorin, Inc.	2019-10-28	89	0
K192064	LIAISON Vitamin B12	DiaSorin, Inc.	2019-10-02	62	0
K182698	LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAI	DiaSorin, Inc.	2018-12-26	90	0
K181464	LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen C	DiaSorin, Inc.	2018-08-31	88	0
K173683	LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN	DiaSorin, Inc.	2018-02-27	88	0
K162969	LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set	DiaSorin, Inc.	2017-01-06	74	0
K162961	LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIA	DiaSorin, Inc.	2017-01-05	73	0
K162959	LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set	DiaSorin, Inc.	2017-01-04	72	0
K160650	LIAISON HAV IgM, LIAISON Control HAV IgM	DiaSorin, Inc.	2016-08-25	170	0
K161139	LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set	DiaSorin, Inc.	2016-07-22	91	0
K161522	LIAISON EBV IgM Serum Control Set	DiaSorin, Inc.	2016-06-30	28	0
K161526	LIAISON CMV IgM Serum Control Set	DiaSorin, Inc.	2016-06-30	28	0
K150879	LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1	DiaSorin, Inc.	2015-06-22	82	0
K150375	LIAISON VZV IgG, LIAISON Control VZV IgG	DiaSorin, Inc.	2015-03-11	26	0
K141463	LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION V	DiaSorin, Inc.	2014-12-10	190	0
K141116	LIAISON XL ANALYZER	DiaSorin, Inc.	2014-07-25	86	0
K132515	LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIER	DiaSorin, Inc.	2013-11-08	88	0
K131037	LIAISON XL HCG	DiaSorin, Inc.	2013-09-06	144	0
K132492	LIAISON 25 TOTAL-D	DiaSorin, Inc.	2013-09-05	27	0
K132234	LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II	DiaSorin, Inc.	2013-08-28	41	0
K131441	LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II	DiaSorin, Inc.	2013-08-09	81	0
K130469	LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYR	DiaSorin, Inc.	2013-04-05	39	0
K121951	LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROI	DiaSorin, Inc.	2013-04-04	275	0
K122793	LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET	DiaSorin, Inc.	2013-01-25	135	0
K121944	LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON EN	DiaSorin, Inc.	2013-01-01	182	0
K122397	LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM	DiaSorin, Inc.	2012-09-06	30	0
K112725	LIAISON 25 OH VITAMIN D TOTAL ASSAY	DiaSorin, Inc.	2012-01-20	122	0
K103529	LIAISON XL ANALYZER MODEL 10050	DiaSorin, Inc.	2011-01-21	51	0
K093498	LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913	DiaSorin, Inc.	2009-12-14	32	0
K090104	LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL:	DiaSorin, Inc.	2009-09-09	237	0
K082049	LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV	DiaSorin, Inc.	2008-12-05	140	0
K073390	DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA	DiaSorin, Inc.	2008-11-21	354	0
K081685	LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG	DiaSorin, Inc.	2008-11-18	154	0
K081687	LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG	DiaSorin, Inc.	2008-11-10	146	1
K082050	LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM	DiaSorin, Inc.	2008-11-03	108	0
K071480	LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIM	DiaSorin, Inc.	2007-10-01	125	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda