ULTRAZYME PLUS AMYL

Catalytic Methods, Amylase

HARLECO DIAGNOSTICS

The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrazyme Plus Amyl.

Pre-market Notification Details

Device IDK821869
510k NumberK821869
Device Name:ULTRAZYME PLUS AMYL
ClassificationCatalytic Methods, Amylase
Applicant HARLECO DIAGNOSTICS 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 Received1982-06-25
Decision Date1982-07-13

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