AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)

COGENT DIAGNOTICS LTD.

The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Anti-gbm Elisa, Hy.tec Anti-gmb Elisa.

Pre-market Notification Details

Device IDK991890
510k NumberK991890
Device Name:AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
ClassificationDevices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
Applicant COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland,  GB Eh26 Opl
ContactDanielle M Knight
CorrespondentDanielle M Knight
COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland,  GB Eh26 Opl
Product CodeMVJ  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-03
Decision Date1999-08-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879020137 K991890 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.