FDA.report

510(k) K210452

Device
Creatinine2
Applicant
Abbott Ireland Diagnostics Division
510(k) number
K210452
Product code
CGX
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-22
Date received
2021-02-16
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
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Magdalena Suszko
Address
Lisnamuck Longford IE

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code CGX

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K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.2024-12-04
K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation2024-11-19
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
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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
K061193CREATININEAbbott Laboratories, Inc.2006-06-23