FDA.reportPublic FDA data

510(k) K161646

Device
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
Applicant
DIAZYME LABORATORIES
510(k) number
K161646
Product code
CGN  
Decision
Substantially Equivalent (SESE)
Decision date
2016-11-04
Date received
2016-06-15
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
ABHIJIT DATTA
Address
12889 Gregg Ct. Poway CA US 92130 92130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233060Elecsys Folate IIIRoche Diagnostics2024-06-17
K223590Access Folate AssayBeckman Coulter, Inc.2023-08-23
K192586LIAISON® FolateDiaSorin, Inc.2020-05-06
K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.2018-04-12
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Decision Summary