FDA.reportPublic FDA data

510(k) K051292

Device
ELECSYS RBC FOLATE HEMOLYZED REAGENT
Applicant
Roche Diagnostics Corp.
510(k) number
K051292
Product code
CGN
Decision
Substantially Equivalent (SESE)
Decision date
2005-06-17
Date received
2005-05-18
Regulation
862.1295
Classification name
Acid, Folic, Radioimmunoassay
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
KAY A TAYLOR
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CGN#

510(k), Device, Applicant table
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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
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