GEMENI URIC ACID U.V.

Acid, Uric, Uricase (u.v.)

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemeni Uric Acid U.v..

Pre-market Notification Details

Device IDK873358
510k NumberK873358
Device Name:GEMENI URIC ACID U.V.
ClassificationAcid, Uric, Uricase (u.v.)
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 CodeCDO  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-21
Decision Date1987-09-11

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