AMYLASE REAGENT

Catalytic Methods, Amylase

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Amylase Reagent.

Pre-market Notification Details

Device IDK912519
510k NumberK912519
Device Name:AMYLASE REAGENT
ClassificationCatalytic Methods, Amylase
Applicant GENZYME CORP. ONE KENDALL SQUARE Cambridge,  MA  02139
ContactRussell H Herndon
CorrespondentRussell H Herndon
GENZYME CORP. ONE KENDALL SQUARE Cambridge,  MA  02139
Product CodeJFJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-06
Decision Date1991-07-01

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