FDA.report

510(k) K251074

Device
Tru Liver Health Test Panel
Applicant
Truvian Health
510(k) number
K251074
Product code
CJE
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-19
Date received
2025-04-08
Regulation
862.1050
Classification name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
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 CJE

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K240468Alkaline PhosphataseAbbott Laboratories Diagnostics Division2024-10-16
K223317Alkaline Phosphatase2Abbott Ireland Diagnostics Division2023-07-21
K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SAS2019-08-30
K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.2018-01-25
K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)2017-05-10
K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)Randox Laboratories Limited2017-04-21
K131351ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENTAlfa Wassermann Diagnostic Technologies, LLC2013-08-15
K130141S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)Hitachi Chemical Diagnostics, Inc.2013-03-22
K113436ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENTAlfa Wassermann2012-07-12
K113269ELITTECH CLINICAL SYSTEMS ALP IFCC SLElitechgroup2011-12-29
K101090EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTSMedica Corp.2011-05-20
K073191ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROLThermofisher Scientific OY2008-02-28
K060205GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx2006-07-21
K033185COBAS INTEGRA ALP IFCC GEN.2Roche Diagnostics Corp.2003-10-14
K023807MODIFICATION TO ALKPAbbott Laboratories2002-12-26