GEM Premier ChemSTAT

Enzymatic Method, Creatinine

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 IDK183555
510k NumberK183555
Device Name:GEM Premier ChemSTAT
ClassificationEnzymatic Method, Creatinine
Applicant Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
ContactGabriella Erdosy
CorrespondentGabriella Erdosy
Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
Product CodeJFY  
Subsequent Product CodeCDQ
Subsequent Product CodeKHS
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-20
Decision Date2019-02-16
Summary:summary

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

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