FDA.report

510(k) K251157

Device
Core Metabolic
Applicant
Truvian Health
510(k) number
K251157
Product code
CIX
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-09
Date received
2025-04-15
Regulation
862.1035
Classification name
Bromcresol Green Dye-Binding, Albumin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Tho Tran
Address
10300 Campus Pt. Dr. Suite 190 San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code CIX

510(k)DeviceApplicantDecision date
K203248Albumin BCG2Abbott Ireland Diagnostics Division2021-11-23
K200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.A2021-09-21
K191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.2019-06-07
K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.2018-04-13
K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC2013-08-19
K113374ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-07-13
K110818POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTSPolymedco, Inc.2011-09-08
K110830ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECHElitechgroup2011-06-21
K101088EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENTMedica Corp.2011-04-04
K080874EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENTMedica Corp.2009-02-20
K072143S40 CLINICAL ANALYZER, S TEST ALBAlfa Wassermann Diagnostic Technologies, Inc.2008-07-14
K060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICALHoriba Abx2007-06-05
K033009ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2Roche Diagnostics Corp.2003-10-16
K030006ATAC PAK ALBUMIN REAGENTElan Diagnostics2003-03-07
K023875VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4Ortho-Clinical Diagnostics, Inc.2002-12-10