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510(k) K011348

Device
PHASE II GBM IGG ANTIBODY EIA TEST
Applicant
SCIMEDX CORP.
510(k) number
K011348
Product code
MVJ  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-25
Date received
2001-05-02
Regulation
866.5660
Classification name
Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Gary Lehnus
Address
400 Ford Rd. Denvill NJ US 07834 07834

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MVJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071219ATHENA MULTI-LYTE GBM TEST SYSTEMZeus Scientific, Inc.2007-12-06
K072358BIOPLEX VASCULITIS KITBio-Rad Laboratories2007-10-31
K991890AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISACogent Diagnotics , Ltd.1999-08-09
K984619BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KITThe Binding Site, Ltd.1999-02-23
K984336QUANTA LITE GBM ELISAInova Diagnostics, Inc.1999-02-08

Legacy Summary#

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FDA Review#

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