Home / 510(k) Clearances / K940682

510(k) K940682

AXSYM(TM) QUINIDINE by Abbott Laboratories — Product Code LGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1994
Date Received
February 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Carbamazepine
Device Class
Class II
Regulation Number
862.3645
Review Panel
TX
Submission Type

Other clearances by Abbott Laboratories

  • K243500 — ARCHITECT iGentamicin (July 9, 2025)
  • K243168 — Alinity i Rubella IgG (June 20, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K232669 — TBI (September 29, 2023)
  • K222850 — HAVAb IgG II (August 10, 2023)
  • K220031 — Alinity h-series System (August 4, 2023)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 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)

Other clearances for product code LGI

  • K944063 — FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE (November 10, 1994)
  • K900702 — MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (April 12, 1990)