GEMSTAR II SYSTEM

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemstar Ii System.

Pre-market Notification Details

Device IDK873617
510k NumberK873617
Device Name:GEMSTAR II SYSTEM
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
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 CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-08
Decision Date1987-10-19

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