AMYLASE LTS

Amyloclastic, Amylase

ELECTRO-NUCLEONICS LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK862640
510k NumberK862640
Device Name:AMYLASE LTS
ClassificationAmyloclastic, Amylase
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
ContactLabrec, Ph.d.
CorrespondentLabrec, Ph.d.
ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
Product CodeCJA  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-10
Decision Date1986-09-09

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