Home / 510(k) Clearances / K842505

510(k) K842505

TDX REA IRON DIAGNOSTIC KIT by Abbott Laboratories — Product Code CFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1984
Date Received
June 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
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 CFM

  • K984119 — WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (January 15, 1999)
  • K981581 — IRON (June 8, 1998)
  • K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER (September 8, 1993)
  • K913705 — ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (October 9, 1991)
  • K912912 — SYNERMED SERUM IRON-600 REAGENT KIT (July 30, 1991)
  • K902918 — SYNERMED SERUM IRON REAGENT KIT (July 31, 1990)
  • K895047 — CLINISTAT POTASSIUM REAGENT TEST (October 17, 1989)
  • K891155 — IRON REAGENT (April 18, 1989)
  • K873120 — ABBOTT A-GENT IRON REAGENT KIT (August 25, 1987)
  • K861602 — TOTAL IRON BINDING CAPACITY PROCEDURE (May 23, 1986)