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510(k) K203771

Device
Urea Nitrogen2
Applicant
Abbott Ireland Diagnostics Division
510(k) number
K203771
Product code
CDQ
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-31
Date received
2020-12-23
Regulation
862.1770
Classification name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tiffini Jenkins
Address
Lisnamuch Longford IE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CDQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140690BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERShenzhen Mindray Bio-Medical Electronics Co., Ltd.2014-09-02
K110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.2011-04-21
K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OY2008-05-29
K070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba Abx2007-10-12
K060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco Diagnostics2006-03-27
K041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, Inc.2004-06-30
K024182PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTSPrecision Systems, Inc.2003-03-03
K021385ATAC PAK BUN REAGENTElan Diagnostics2002-07-12
K012649RAICHEM BUN RATE REAGENTHemagen Diagnostics, Inc.2001-10-15
K012260WIENER LAB. UREA UV CINETICA AAWiener Laboratories Saic2001-09-19
K011596UREA NITROGEN (BUN) LIQUID REAGENTJas Diagnostic, Inc.2001-07-17
K002694UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30Diagnostic Chemicals , Ltd.2000-09-15
K000958ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITSElan Holdings, Inc.2000-05-24
K993925WAKO L-TYPE UN TESTWako Chemicals USA, Inc.2000-04-03
K993178UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50Diagnostic Chemicals , Ltd.1999-10-18