HEXOKINASE, GLUCOSE

Hexokinase, Glucose

BECKMAN INSTRUMENTS, INC.

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

Pre-market Notification Details

Device IDK802810
510k NumberK802810
Device Name:HEXOKINASE, GLUCOSE
ClassificationHexokinase, Glucose
Applicant BECKMAN INSTRUMENTS, 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 Received1980-11-07
Decision Date1980-12-10

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