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510(k) K103529

LIAISON XL ANALYZER MODEL 10050 by DiaSorin, Inc. — Product Code LOL

K103529 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON XL ANALYZER MODEL 10050". The FDA issued a decision of Substantially Equivalent on January 21, 2011. The device falls under product code LOL (Hepatitis A Test (Antibody And Igm Antibody)), a Class II device regulated under 21 CFR 866.3310. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2011
Date Received
December 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Device Class
Class II
Regulation Number
866.3310
Review Panel
MI
Submission Type

Other clearances by DiaSorin, Inc.

  • K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (June 4, 2026)
  • DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (December 23, 2025)
  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K223403 — LIAISON Anti-HAV; LIAISON XS (December 9, 2022)
  • K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (July 26, 2022)
  • K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set (July 14, 2022)
  • K193650 — LIAISON Ferritin (September 14, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K210272 — LIAISON Anti-HAV (February 9, 2021)

Other clearances for product code LOL

  • K260048 — Elecsys Anti-HAV IgM (April 7, 2026)
  • K251995 — Access anti-HAV IgM (January 27, 2026)
  • K243846 — Access anti-HAV (September 9, 2025)
  • K222850 — HAVAb IgG II (August 10, 2023)
  • K223403 — LIAISON Anti-HAV; LIAISON XS (December 9, 2022)
  • K210272 — LIAISON Anti-HAV (February 9, 2021)
  • K193532 — LIAISON Anti-HAV Assay (March 2, 2020)
  • K190428 — Elecsys Anti-HAV II (August 13, 2019)
  • K161964 — ADVIA Centaur HAV IgM Assay (October 13, 2016)
  • K160650 — LIAISON HAV IgM, LIAISON Control HAV IgM (August 25, 2016)

FDA data resources