PSI AMYLASE REAGENT

Catalytic Methods, Amylase

POINTE SCIENTIFIC, INC.

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

Pre-market Notification Details

Device IDK864464
510k NumberK864464
Device Name:PSI AMYLASE REAGENT
ClassificationCatalytic Methods, Amylase
Applicant POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit,  MI  48224
ContactWilliam F Walters
CorrespondentWilliam F Walters
POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit,  MI  48224
Product CodeJFJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-12
Decision Date1987-01-21

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