FDA.reportPublic FDA data

510(k) K071510

Device
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
Applicant
Focus Diagnostics, Inc.
510(k) number
K071510
Product code
MXJ
Decision
Substantially Equivalent (SESE)
Decision date
2007-09-24
Date received
2007-06-04
Regulation
866.3305
Classification name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
CONSTANCE BRIDGES
Address
10703 Progress Way Cypress CA US 90630 90630

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MXJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics2022-10-12
K181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.2018-08-23
K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc.2016-10-01
K143236Theranos Herpes Simplex Virus-1 IgG AssayTheranos, Inc.2015-07-02
K131334HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TESTGold Standard Diagnostics2014-02-28
K120625ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSVRoche Diagnostics2012-07-25
K120959BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITBio-Rad Laboratories2012-06-22
K103363ZEUS ELISA HSV GC-I IGG TEST SYSTEMZeus Scientific, Inc.2011-04-26
K090409BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories2009-05-08
K081685LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGGDiaSorin, Inc.2008-11-18
K072178ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEMZeus Scientific, Inc.2008-05-30
K071511PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900GFocus Diagnostics, Inc.2007-10-05
K062543HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900GFocus Diagnostics, Inc.2007-02-01
K033105CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KITTrinity Biotech USA2004-07-13