ENI BLOOD UREA NITROGEN REAGENT

Urease And Glutamic Dehydrogenase, Urea Nitrogen

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Eni Blood Urea Nitrogen Reagent.

Pre-market Notification Details

Device IDK844065
510k NumberK844065
Device Name:ENI BLOOD UREA NITROGEN REAGENT
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
ContactEugene H Labrec
CorrespondentEugene H Labrec
ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
Product CodeCDQ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-18
Decision Date1984-11-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.