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

Ph Rate Measurement, Carbon-dioxide

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 IDK191298
510k NumberK191298
Device Name:I-STAT CHEM8+ Cartridge With The I-STAT 1 System
ClassificationPh Rate Measurement, Carbon-dioxide
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 CodeJFL  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-14
Decision Date2020-02-07

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