Amylase2

Catalytic Methods, Amylase

Abbott Ireland Diagnostics Division

The following data is part of a premarket notification filed by Abbott Ireland Diagnostics Division with the FDA for Amylase2.

Pre-market Notification Details

Device IDK210633
510k NumberK210633
Device Name:Amylase2
ClassificationCatalytic Methods, Amylase
Applicant Abbott Ireland Diagnostics Division Lisnarnuck Longford,  IE
ContactMagdalena Suszko
CorrespondentMagdalena Suszko
Abbott Ireland Diagnostics Division Lisnarnuck Longford,  IE
Product CodeJFJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-03
Decision Date2022-05-26

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