CGX — Alkaline Picrate, Colorimetry, Creatinine Class II

FDA Device Classification

Classification Details

Product Code
CGX
Device Class
Class II
Regulation Number
862.1225
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252206nova biomedical corporationNova Allegro UACR Assay, Nova Allegro AnalyzerJanuary 9, 2026
K251058truvian healthTru Kidney Health Test Panel; Tru AnalyzerNovember 26, 2025
K242685siemens healthcare diagnosticsAtellica® CH Creatinine_3 (Crea3)December 4, 2024
K221813nova biomedical corporationNova Allegro UACR Assay, Nova Allegro AnalyzerNovember 19, 2024
K210452abbott ireland diagnostics divisionCreatinine2March 22, 2022
K161494siemens healthcare diagnosticsAtellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)November 15, 2016
K132638siemens healthcare diagnosticsDIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGEJanuary 27, 2014
K133728siemens healthcare diagnosticsDIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGEJanuary 24, 2014
K123586medica corporationEASYRA CREATININE REAGENTMay 15, 2013
K110530horiba abxABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PEApril 30, 2012
K083809abbott laboratoriesCREATININEApril 7, 2009
K072115horiba abxABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, November 30, 2007
K071283beckman coulterSYNCHRON SYSTEMS CREATININE REAGENTJune 1, 2007
K071280beckman coulterSYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMSJune 1, 2007
K071277beckman coulterSYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMSJune 1, 2007
K061193abbott laboratoriesCREATININEJune 23, 2006
K060935beckman coulterSYNCHRON SYSTEMS CREATININE (CREA) REAGENTApril 28, 2006
K050652arkraySPOTCHEM II CREATININE, AMYLASE & ALP TESTSApril 6, 2005
K040976genchemGENCHEM CREATININE REAGENTDecember 27, 2004
K033058diamond diagnosticsCREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMSJanuary 30, 2004