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510(k) K131037

LIAISON XL HCG by DiaSorin, Inc. — Product Code DHA

K131037 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON XL HCG". The FDA issued a decision of Substantially Equivalent on September 6, 2013. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2013
Date Received
April 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by DiaSorin, Inc.

  • K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (June 4, 2026)
  • 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)

Other clearances for product code DHA

  • K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (May 8, 2024)
  • K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (December 11, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)
  • K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT (May 19, 2023)
  • K221990 — Access Total ßhCG (5th IS) (December 27, 2022)
  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203227 — Elecsys HCG STAT (August 18, 2021)
  • K200210 — ADVIA Centaur® Total hCG assay (July 13, 2021)
  • K192547 — MAGLUMI 2000 HCG/ß-HCG (January 17, 2020)
  • K192790 — Atellica IM Total hCG (ThCG) (October 30, 2019)

FDA data resources