510(k) K082340

Device: ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
Applicant: ROCHE DIAGNOSTICS CORP.
510(k) number: K082340
Product code: CGN
Decision: Substantially Equivalent (SESE)
Decision date: 2009-06-19
Date received: 2008-08-15
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: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K233060	Elecsys Folate III	Roche Diagnostics	2024-06-17
K223590	Access Folate Assay	Beckman Coulter, Inc.	2023-08-23
K192586	LIAISON® Folate	DiaSorin, Inc.	2020-05-06
K172201	Atellica IM Folate Assay	Siemens Healthcare Diagnostics, Inc.	2018-04-12
K161646	Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set	Diazyme Laboratories	2016-11-04
K141426	ELECSYS FOLATE III	Roche Diagnostics	2014-10-17
K103716	ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET	Roche Diagnostics	2011-05-12
K092740	ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74	Abbott Laboratories	2010-03-05
K091332	AIA-PACK RBC FOLATE	Tosoh Bioscience, Inc.	2009-10-02
K060774	FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208	Beckman Coulter, Inc.	2006-04-21
K051292	ELECSYS RBC FOLATE HEMOLYZED REAGENT	Roche Diagnostics Corp.	2005-06-17
K043318	MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY	Roche Diagnostics Corp.	2004-12-23
K031756	ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY	Roche Diagnostics Corp.	2003-06-25
K023397	ABBOTT ARCHITECT FOLATE	Abbott Laboratories	2002-12-16
K010050	ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY	Bayer Diagnostics Corp.	2001-02-05

summary

Decision Summary