AMYLASE

Saccharogenic, Amylase

AC BIOCHEMICALS, INC.

The following data is part of a premarket notification filed by Ac Biochemicals, Inc. with the FDA for Amylase.

Pre-market Notification Details

Device IDK980013
510k NumberK980013
Device Name:AMYLASE
ClassificationSaccharogenic, Amylase
Applicant AC BIOCHEMICALS, INC. 17955 SKY PARK CIRCLE, SUITE J Irvine,  CA  92614
ContactCharles C Allain
CorrespondentCharles C Allain
AC BIOCHEMICALS, INC. 17955 SKY PARK CIRCLE, SUITE J Irvine,  CA  92614
Product CodeCIJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-02
Decision Date1998-02-04

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