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510(k) K141116

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2014
Date Received
April 30, 2014
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

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  • 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)
  • K142758 — ADVIA Centaur HAV total assay (December 5, 2014)