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510(k) K223590

Device
Access Folate Assay
Applicant
Beckman Coulter, Inc.
510(k) number
K223590
Product code
CGN
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-23
Date received
2022-12-01
Regulation
862.1295
Classification name
Acid, Folic, Radioimmunoassay
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
Dr. Kuljeet Kaur
Address
1000 Lake Hazeline Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CGN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233060Elecsys Folate IIIRoche Diagnostics2024-06-17
K192586LIAISON® FolateDiaSorin, Inc.2020-05-06
K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.2018-04-12
K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetDiazyme Laboratories2016-11-04
K141426ELECSYS FOLATE IIIRoche Diagnostics2014-10-17
K103716ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSETRoche Diagnostics2011-05-12
K092740ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74Abbott Laboratories2010-03-05
K091332AIA-PACK RBC FOLATETosoh Bioscience, Inc.2009-10-02
K082340ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYSRoche Diagnostics Corp.2009-06-19
K060774FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208Beckman Coulter, Inc.2006-04-21
K051292ELECSYS RBC FOLATE HEMOLYZED REAGENTRoche Diagnostics Corp.2005-06-17
K043318MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAYRoche Diagnostics Corp.2004-12-23
K031756ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAYRoche Diagnostics Corp.2003-06-25
K023397ABBOTT ARCHITECT FOLATEAbbott Laboratories2002-12-16
K010050ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAYBayer Diagnostics Corp.2001-02-05