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510(k) K973993

Device
RANDOX CREATININE
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K973993
Product code
CGX  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-06
Date received
1997-10-21
Regulation
862.1225
Classification name
Alkaline Picrate, Colorimetry, Creatinine
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
P ARMSTRONG
Address
Ardmore, Diamond Rd. Crumlin IE BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation2026-01-09
K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health2025-11-26
K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.2024-12-04
K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation2024-11-19
K210452Creatinine2Abbott Ireland Diagnostics Division2022-03-22
K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc.2016-11-15
K132638DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics, Inc.2014-01-27
K133728DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics, Inc.2014-01-24
K123586EASYRA CREATININE REAGENTMedica Corporation2013-05-15
K110530ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROLHORIBA ABX SAS2012-04-30
K083809CREATININEAbbott Laboratories2009-04-07
K072115ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/HHoriba Abx2007-11-30
K071277SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMSBeckman Coulter, Inc.2007-06-01
K071280SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMSBeckman Coulter, Inc.2007-06-01
K071283SYNCHRON SYSTEMS CREATININE REAGENTBeckman Coulter, Inc.2007-06-01

Legacy Summary#

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FDA Review#

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