GLUCOSE HEXOKINASE COIL REAGENT SYSTEM

Hexokinase, Glucose

FISHER SCIENTIFIC CO., LLC.

The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Glucose Hexokinase Coil Reagent System.

Pre-market Notification Details

Device IDK791760
510k NumberK791760
Device Name:GLUCOSE HEXOKINASE COIL REAGENT SYSTEM
ClassificationHexokinase, Glucose
Applicant FISHER SCIENTIFIC CO., LLC. 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 Received1979-09-05
Decision Date1979-09-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.