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CIX — Bromcresol Green Dye-Binding, Albumin Class II

FDA Device Classification

Classification Details

Product Code
CIX
Device Class
Class II
Regulation Number
862.1035
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251157truvian healthCore MetabolicJanuary 9, 2026
K203248abbott ireland diagnostics divisionAlbumin BCG2November 23, 2021
K200898medicon hellasMedicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, MedicSeptember 21, 2021
K191316ortho-clinical diagnosticsVITROS XT Chemistry Products ALB-TP SlidesJune 7, 2019
K170901biosystemsALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400April 13, 2018
K131488alfa wassermann diagnostics technologiesACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT ANDAugust 19, 2013
K113374alfa wassermann diagnostic technologiesACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PJuly 13, 2012
K110818polymedcoPOLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEISeptember 8, 2011
K110830elitechgroupELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELIJune 21, 2011
K101088medicaEASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENTApril 4, 2011
K080874medicaEASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENTFebruary 20, 2009
K072143alfa wassermann diagnostic technologiesS40 CLINICAL ANALYZER, S TEST ALBJuly 14, 2008
K060434horiba abxABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP,June 5, 2007
K033009roche diagnosticsROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2October 16, 2003
K030006elan diagnosticsATAC PAK ALBUMIN REAGENTMarch 7, 2003
K023875ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4December 10, 2002
K022072precision systemsPRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTAugust 23, 2002
K012329wiener laboratories saicWIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300September 21, 2001
K011720olympus americaOLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZERJune 25, 2001
K010877awareness technologyCHEMWELL, MODEL 2900May 23, 2001