Home / 510(k) Clearances / K251995

510(k) K251995

Access anti-HAV IgM by Beckman Coulter, Inc. — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2026
Date Received
June 27, 2025
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 Beckman Coulter, Inc.

  • K254059 — Access anti-HBc IgM (March 13, 2026)
  • K253687 — Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access (February 19, 2026)
  • K250588 — Access Rubella IgG (November 17, 2025)
  • K252580 — iQ200 Series (September 10, 2025)
  • K243846 — Access anti-HAV (September 9, 2025)
  • K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/m (August 20, 2025)
  • K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg (August 15, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/m (July 18, 2025)
  • K242870 — Access hsTnI (June 16, 2025)

Other clearances for product code LOL

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