AUTOLOADER II

Station, Pipetting And Diluting, 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 Autoloader Ii.

Pre-market Notification Details

Device IDK843779
510k NumberK843779
Device Name:AUTOLOADER II
ClassificationStation, Pipetting And Diluting, For Clinical Use
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 CodeJQW  
CFR Regulation Number862.2750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-25
Decision Date1985-01-03

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