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

Device, Hematocrit Measuring

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 IDK183680
510k NumberK183680
Device Name:I-STAT CHEM8+ Cartridge With The I-STAT 1 System
ClassificationDevice, Hematocrit Measuring
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 CodeJPI  
CFR Regulation Number864.6400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyHematology
510k Review PanelHematology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-28
Decision Date2020-02-28

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