FDA.reportPublic FDA data

510(k) K231214

Device
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
Applicant
DiaSorin, Inc.
510(k) number
K231214
Product code
LFY
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-27
Date received
2023-04-28
Regulation
866.3900
Classification name
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kelly Olien
Address
1952 Northwestern Ave. Stillwater MN US 55082 55082

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LFY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150375LIAISON VZV IgG, LIAISON Control VZV IgGDiaSorin, Inc.2015-03-11
K070317ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEMZeus Scientific, Inc.2007-07-05
K061820DIASORIN LIAISON VZV IGGDiaSorin, Inc.2007-02-26
K051484ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.Zeus Scientific, Inc.2005-12-05
K984181THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEMZeus Scientific, Inc.1999-01-22
K981867IS-VZU IGG TEST SYSTEMDiamedix Corp.1998-09-28
K972295SERAQUEST VZV IGGQuest Intl., Inc.1997-11-05
K961012VZV IGG ELISA TEST SYSTEMZeus Scientific, Inc.1996-07-24
K943843VARICELISA, MODIFICATIONBiowhittaker Molecular Applications, Inc.1996-03-14
K941046VZV IGG ELISA TESTGull Laboratories, Inc.1995-08-24
K923122VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMBiomerieux Vitek, Inc.1992-10-26
K914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSPharmacia Diagnostics, Inc.1992-01-27
K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITClinical Sciences, Inc.1990-05-15
K890642VZV MICROASSAYDiamedix Corp.1989-05-15
K833637VZV BIO-ENZABEAD SCREEN KITBionetic Laboratory Products1984-02-10