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510(k) K131554

Device
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K131554
Product code
JJE  
Decision
Substantially Equivalent (SESE)
Decision date
2014-01-09
Date received
2013-05-30
Regulation
862.2160
Classification name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAULINE ARMSTRONG
Address
55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JJE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.2019-02-12
K133519CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CARCarolina Liquid Chemistries Corp.2014-05-16
K130915XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACKJas Diagnostics, Inc.2014-05-15
K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.2013-03-22
K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-05-17
K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare Diagnostics2011-11-22
K110035INDIKOThermofisher Scientific OY2011-06-28
K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics2008-05-08
K063144VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEMOrtho-Clinical Diagnostics, Inc.2006-11-13
K051087DIMENSION VISTA INTEGRATED SYSTEMDade Behring, Inc.2005-07-11
K042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERStanbio Laboratory2005-03-14
K040958PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240Tokyo Boeki Medical System , Ltd.2005-02-15
K023764UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100Beckman Coulter, Inc.2003-01-28
K010500AUTOMATED WORKCELL CONTROL SOFTWARELab-Interlink, Inc.2001-08-01
K003721MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.2000-12-18

Legacy Summary#

summary

FDA Review#

Decision Summary