GEM Premier ChemSTAT

Glucose Oxidase, Glucose

Instrumentation Laboratory Co.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier Chemstat.

Pre-market Notification Details

Device IDK183546
510k NumberK183546
Device Name:GEM Premier ChemSTAT
ClassificationGlucose Oxidase, Glucose
Applicant Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
ContactGabriella Erdosy
CorrespondentGabriella Erdosy
Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
Product CodeCGA  
Subsequent Product CodeCHL
Subsequent Product CodeGKF
Subsequent Product CodeKHP
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-20
Decision Date2019-02-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426951293865 K183546 000

Trademark Results [GEM Premier ChemSTAT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GEM PREMIER CHEMSTAT
GEM PREMIER CHEMSTAT
86815492 not registered Live/Pending
Instrumentation Laboratory Company
2015-11-10

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