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510(k) K923507

Device
ALKALINE PHOSPHATASE KIT
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K923507
Product code
CJE  
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-03
Date received
1992-07-15
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
John Lamont
Address
Ardmore, Diamond Rd. Crumlin, Bt29 4qy Co. Antrim, N. Ireland IR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CJE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251074Tru Liver Health Test PanelTruvian Health2025-12-19
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

Legacy Summary#

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FDA Review#

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