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510(k) K160650

LIAISON HAV IgM, LIAISON Control HAV IgM by DiaSorin, Inc. — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2016
Date Received
March 8, 2016
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

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Other clearances for product code LOL

  • K251995 — Access anti-HAV IgM (January 27, 2026)
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  • 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)
  • K142758 — ADVIA Centaur HAV total assay (December 5, 2014)
  • K141116 — LIAISON XL ANALYZER (July 25, 2014)