I-STAT CHEM8+ Cartridge With The I-STAT 1 System

Glucose Oxidase, Glucose

Abbott Point Of Care, Inc.

The following data is part of a premarket notification filed by Abbott Point Of Care, Inc. with the FDA for I-stat Chem8+ Cartridge With The I-stat 1 System.

Pre-market Notification Details

Device IDK183678
510k NumberK183678
Device Name:I-STAT CHEM8+ Cartridge With The I-STAT 1 System
ClassificationGlucose Oxidase, Glucose
Applicant Abbott Point Of Care, Inc. 400 College Road East Princeton,  NJ  08540
ContactSusan Tibedo
CorrespondentSusan Tibedo
Abbott Point Of Care, Inc. 400 College Road East Princeton,  NJ  08540
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-28
Decision Date2020-02-07

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