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510(k) K210452

Creatinine2 by Abbott Ireland Diagnostics Division — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2022
Date Received
February 16, 2021
Clearance Type
Traditional
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

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  • 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)
  • K083809 — CREATININE (April 7, 2009)