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510(k) K072409

AFINION ACR AND ACR CONTROL by Axis-Shield Poc AS — Product Code JFY

K072409 is an FDA 510(k) premarket notification submitted by Axis-Shield Poc AS for the device "AFINION ACR AND ACR CONTROL". The FDA issued a decision of Substantially Equivalent on February 12, 2008. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Axis-Shield Poc AS has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2008
Date Received
August 27, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Axis-Shield Poc AS

  • K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (March 21, 2014)
  • K110056 — AFINION ANALYZER (February 15, 2011)
  • K050574 — AFINION HBALC (July 22, 2005)

Other clearances for product code JFY

  • K252619 — QSCHECK UISACR (February 20, 2026)
  • K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3) (November 24, 2021)
  • K193649 — Yumizen C1200 Creatinine PAP (May 10, 2021)
  • K182384 — ACR LAB Urine Analysis Test System (July 26, 2019)
  • K183555 — GEM Premier ChemSTAT (February 16, 2019)
  • K182038 — URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer (December 10, 2018)
  • K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VI (October 30, 2018)
  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbu (December 22, 2014)

FDA data resources