FDA.reportPublic FDA data

510(k) K033059

Device
HERPES GROUP IGG
Applicant
TRINITY BIOTECH, INC.
510(k) number
K033059
Product code
LGC  
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-26
Date received
2003-09-29
Regulation
866.3305
Classification name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BONNIE DEJOY
Address
P.O. Box 1059 Jamestown NY US 14702 14702

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LGC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.2001-04-18
K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.2000-11-28
K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl Diagnostics2000-04-14
K992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.1999-09-03
K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.1999-08-19
K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTMeridian Diagnostics, Inc.1999-06-25
K983656HSV-1 AND/OR -2 IGM ELISA TEST SYSTEMZeus Scientific, Inc.1999-03-18
K983541HSV 1+2 IGG ELISA TESTGull Laboratories, Inc.1999-02-26
K981306DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEMDiamedix Corp.1998-09-29
K963645HERPES GROUP IGG ELISA TEST SYSTEMArmkel, LLC1997-02-04
K963282SERAQUEST HSV IGGQuest Intl., Inc.1997-01-22
K950670IMMULITE HERPES I AND II IGGDiagnostic Products Corp.1996-06-21
K953839PREMIER HSV PLUSMeridian Diagnostics, Inc.1996-05-23
K925208ORTHO HSV ANTIGEN ELISA TEST, MODIFICATIONOrtho Diagnostic Systems, Inc.1992-12-28
K922333BARTELS HERPES SIMPLEX VIRUS 2 IGM EIABaxter Diagnostics, Inc.1992-12-15

Legacy Summary#

summary

FDA Review#

Decision Summary