AMYLAST-D TEST

Catalytic Methods, Amylase

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Amylast-d Test.

Pre-market Notification Details

Device IDK831561
510k NumberK831561
Device Name:AMYLAST-D TEST
ClassificationCatalytic Methods, Amylase
Applicant SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJFJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-16
Decision Date1983-07-07

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