VIRGO(TM) RUBELLA IGG ELISA

Enzyme Linked Immunoabsorbent Assay, Rubella

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) Rubella Igg Elisa.

Pre-market Notification Details

Device IDK873088
510k NumberK873088
Device Name:VIRGO(TM) RUBELLA IGG ELISA
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
ContactLabrec, Phd
CorrespondentLabrec, Phd
ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-05
Decision Date1987-09-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391516747004 K873088 000
05391516743433 K873088 000
05391516746786 K873088 000
05391516746748 K873088 000
05391516746878 K873088 000
05391516746533 K873088 000
05391516746526 K873088 000
05391516746519 K873088 000

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