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510(k) K981758

Device
ALBG
Applicant
ABBOTT LABORATORIES
510(k) number
K981758
Product code
CIX  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-12
Date received
1998-05-19
Regulation
862.1035
Classification name
Bromcresol Green Dye-binding, Albumin
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
MARK LITTLEFIELD
Address
Dept. 09va Lc-2 1920 Hurd Dr. Irving TX US 75038 75038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CIX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251157Core MetabolicTruvian Health2026-01-09
K203248Albumin BCG2Abbott Ireland Diagnostics Division2021-11-23
K200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.A2021-09-21
K191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.2019-06-07
K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.2018-04-13
K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC2013-08-19
K113374ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-07-13
K110818POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTSPolymedco, Inc.2011-09-08
K110830ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECHElitechgroup2011-06-21
K101088EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENTMedica Corp.2011-04-04
K080874EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENTMedica Corp.2009-02-20
K072143S40 CLINICAL ANALYZER, S TEST ALBAlfa Wassermann Diagnostic Technologies, Inc.2008-07-14
K060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICALHoriba Abx2007-06-05
K033009ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2Roche Diagnostics Corp.2003-10-16
K030006ATAC PAK ALBUMIN REAGENTElan Diagnostics2003-03-07

Legacy Summary#

summary

FDA Review#

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