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510(k) K193532

LIAISON Anti-HAV Assay by DiaSorin, Inc. — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2020
Date Received
December 20, 2019
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.

  • 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)
  • K201908 — LIAISON Testosterone xt (October 15, 2020)

Other clearances for product code LOL

  • 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)
  • 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)
  • K142758 — ADVIA Centaur HAV total assay (December 5, 2014)
  • K141116 — LIAISON XL ANALYZER (July 25, 2014)