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CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Class II

FDA Device Classification

Classification Details

Product Code
CJE
Device Class
Class II
Regulation Number
862.1050
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251074truvian healthTru Liver Health Test PanelDecember 19, 2025
K240468abbott laboratories diagnostics divisionAlkaline PhosphataseOctober 16, 2024
K223317abbott ireland diagnostics divisionAlkaline Phosphatase2July 21, 2023
K191245horiba abxYumizen C1200 ALP, Yumizen C1200 AlbuminAugust 30, 2019
K171971lite-on technology corp. h.s.p.bComprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 January 25, 2018
K171080roche diagnostics operations (rdo)ALP IFCC Gen.2May 10, 2017
K162275randox laboratories limitedRandox RX Daytona Plus Alkaline Phosphatase (ALP)April 21, 2017
K131351alfa wassermann diagnostic technologiesACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENTAugust 15, 2013
K130141hitachi chemical diagnosticsS TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)March 22, 2013
K113436alfa wassermannACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENTJuly 12, 2012
K113269elitechgroupELITTECH CLINICAL SYSTEMS ALP IFCC SLDecember 29, 2011
K101090medicaEASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTSMay 20, 2011
K073191thermofisher scientificALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROLFebruary 28, 2008
K060205horiba abxGENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERJuly 21, 2006
K033185roche diagnosticsCOBAS INTEGRA ALP IFCC GEN.2October 14, 2003
K023807abbott laboratoriesMODIFICATION TO ALKPDecember 26, 2002
K013983wiener laboratories saicWIENER LAB. ALP 405January 28, 2002
K012518thermo dmaTRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113October 9, 2001
K011599jas diagnosticsALKALINE PHOSPHATASE LIQUID REAGENTJuly 20, 2001
K003093diagnostic chemicalsALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30November 27, 2000