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510(k) K100903

Device
ANTI-HAV
Applicant
ROCHE PROFESSIONAL DIAGNOSTICS
510(k) number
K100903
Product code
LOL  
Decision
Substantially Equivalent (SESE)
Decision date
2010-10-05
Date received
2010-04-01
Regulation
866.3310
Classification name
Hepatitis A Test (antibody And Igm Antibody)
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KELLY FRENCH
Address
9115 Hague Rd. P.O. Box 50410 Indianapolis IN US

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LOL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260048Elecsys Anti-HAV IgMRoche Diagnostics2026-04-07
K251995Access anti-HAV IgMBeckman Coulter, Inc.2026-01-27
K243846Access anti-HAVBeckman Coulter, Inc.2025-09-09
K222850HAVAb IgG IIAbbott Laboratories2023-08-10
K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.2022-12-09
K210272LIAISON Anti-HAVDiaSorin, Inc.2021-02-09
K193532LIAISON Anti-HAV AssayDiaSorin, Inc.2020-03-02
K190428Elecsys Anti-HAV IIRoche Diagnostics2019-08-13
K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc.2016-10-13
K160650LIAISON HAV IgM, LIAISON Control HAV IgMDiaSorin, Inc.2016-08-25
K142758ADVIA Centaur HAV total assaySiemens Healthcare Diagnostics, Inc.2014-12-05
K141116LIAISON XL ANALYZERDiaSorin, Inc.2014-07-25
K113704ARCHITECT HAVAB-GAbbott Laboratories2012-06-28
K103529LIAISON XL ANALYZER MODEL 10050DiaSorin, Inc.2011-01-21
K093955ANTI-HAV IGMRoche Diagnostics2010-06-22

Legacy Summary#

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FDA Review#

Decision Summary