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510(k) K991890

Device
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
Applicant
COGENT DIAGNOTICS LTD.
510(k) number
K991890
Product code
MVJ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-08-09
Date received
1999-06-03
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
DANIELLE M KNIGHT
Address
Pentlands Science Park Bush Loan, Penicuik Midlothian, Scotland GB EH26 OPL EH26 OPL

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
K011348PHASE II GBM IGG ANTIBODY EIA TESTScimedx Corp.2001-06-25
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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