ULTRAZYME PLUS GOT

Nadh Oxidation/nad Reduction, Ast/sgot

HARLECO DIAGNOSTICS

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

Pre-market Notification Details

Device IDK821876
510k NumberK821876
Device Name:ULTRAZYME PLUS GOT
ClassificationNadh Oxidation/nad Reduction, Ast/sgot
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIT  
CFR Regulation Number862.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-25
Decision Date1982-07-13

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