Stat Profile Prime Plus Analyzer System

Glucose Oxidase, Glucose

Nova Biomedical Corporation

The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Stat Profile Prime Plus Analyzer System.

Pre-market Notification Details

Device IDK200349
510k NumberK200349
Device Name:Stat Profile Prime Plus Analyzer System
ClassificationGlucose Oxidase, Glucose
Applicant Nova Biomedical Corporation 200 Prospect Street Waltham,  MA  02454
ContactRachel Gilbert
CorrespondentRachel Gilbert
Nova Biomedical Corporation 200 Prospect Street Waltham,  MA  02454
Product CodeCGA  
Subsequent Product CodeCDS
Subsequent Product CodeCGL
Subsequent Product CodeKHP
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-12
Decision Date2020-03-13

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