CARDIOLIPIN G EIA TEST SYSTEM

System, Test, Anticardiolipin Immunological

HOGAN & HARTSON

The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Cardiolipin G Eia Test System.

Pre-market Notification Details

Device IDK946215
510k NumberK946215
Device Name:CARDIOLIPIN G EIA TEST SYSTEM
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington,  DC  20004
ContactEdward C Wilson
CorrespondentEdward C Wilson
HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington,  DC  20004
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-21
Decision Date1996-01-24

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