VIRGO(TM) MEASLES IGG ELISA

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Virgo(tm) Measles Igg Elisa.

Pre-market Notification Details

Device IDK873925
510k NumberK873925
Device Name:VIRGO(TM) MEASLES IGG ELISA
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
ContactLabrec, Ph.d.
CorrespondentLabrec, Ph.d.
ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
Product CodeLJB  
CFR Regulation Number866.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-25
Decision Date1988-02-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391516747127 K873925 000
05391516743631 K873925 000

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