AMYLASE

Catalytic Methods, Amylase

POINTE SCIENTIFIC, INC.

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

Pre-market Notification Details

Device IDK832889
510k NumberK832889
Device Name:AMYLASE
ClassificationCatalytic Methods, Amylase
Applicant POINTE SCIENTIFIC, 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 Received1983-08-22
Decision Date1983-11-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.