RO EIA TEST KIT

Antinuclear Antibody (enzyme-labeled), Antigen, Controls

DAVID A. FUCCILLO, PH.D.

The following data is part of a premarket notification filed by David A. Fuccillo, Ph.d. with the FDA for Ro Eia Test Kit.

Pre-market Notification Details

Device IDK935416
510k NumberK935416
Device Name:RO EIA TEST KIT
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
Applicant DAVID A. FUCCILLO, PH.D. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
ContactPatricia B Shrader
CorrespondentPatricia B Shrader
DAVID A. FUCCILLO, PH.D. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
Product CodeLJM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-09
Decision Date1994-05-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391516743747 K935416 000

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