VIRGO HSV-1 IGG ELISA

Antisera, Cf, Herpesvirus Hominis 1,2

ELECTRO-NUCLEONICS, INC.

The following data is part of a premarket notification filed by Electro-nucleonics, Inc. with the FDA for Virgo Hsv-1 Igg Elisa.

Pre-market Notification Details

Device IDK883282
510k NumberK883282
Device Name:VIRGO HSV-1 IGG ELISA
ClassificationAntisera, Cf, Herpesvirus Hominis 1,2
Applicant ELECTRO-NUCLEONICS, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046 -1297
ContactKaren Darcy
CorrespondentKaren Darcy
ELECTRO-NUCLEONICS, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046 -1297
Product CodeGQO  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-03
Decision Date1989-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391516747028 K883282 000
05391516743464 K883282 000

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