GLUCOSE HEXOKINASE DIAG. KIT

Hexokinase, Glucose

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Glucose Hexokinase Diag. Kit.

Pre-market Notification Details

Device IDK831560
510k NumberK831560
Device Name:GLUCOSE HEXOKINASE DIAG. KIT
ClassificationHexokinase, Glucose
Applicant SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-16
Decision Date1983-07-06

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