Home / 510(k) Clearances / K083809

510(k) K083809

CREATININE by Abbott Laboratories — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2009
Date Received
December 22, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
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 CGX

  • K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer (January 9, 2026)
  • K251058 — Tru Kidney Health Test Panel; Tru Analyzer (November 26, 2025)
  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer (November 19, 2024)
  • K210452 — Creatinine2 (March 22, 2022)
  • K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (November 15, 2016)
  • K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 27, 2014)
  • K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 24, 2014)
  • K123586 — EASYRA CREATININE REAGENT (May 15, 2013)
  • K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PE (April 30, 2012)