CARDIOLIPIN IGG,M,A EIA TEST SYSTEM

System, Test, Anticardiolipin Immunological

IMMUNO PROBE, INC.

The following data is part of a premarket notification filed by Immuno Probe, Inc. with the FDA for Cardiolipin Igg,m,a Eia Test System.

Pre-market Notification Details

Device IDK951363
510k NumberK951363
Device Name:CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant IMMUNO PROBE, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington,  DC  20004 -1109
ContactEdward C Wilson
CorrespondentEdward C Wilson
IMMUNO PROBE, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington,  DC  20004 -1109
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-24
Decision Date1995-10-13

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