Home / 510(k) Clearances / K190428

510(k) K190428

Elecsys Anti-HAV II by Roche Diagnostics — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2019
Date Received
February 22, 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 Roche Diagnostics

  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)
  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K252163 — Elecsys Phospho-Tau (181P) Plasma (October 8, 2025)
  • K242505 — Elecsys Cortisol III (July 17, 2025)
  • K250768 — Elecsys Anti-SARS-CoV-2 (June 10, 2025)
  • K241453 — Elecsys sFlt-1 and Elecsys PlGF (February 7, 2025)
  • K233060 — Elecsys Folate III (June 17, 2024)
  • K220272 — cobas pulse blood glucose monitoring system (April 26, 2024)

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)
  • K193532 — LIAISON Anti-HAV Assay (March 2, 2020)
  • 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)