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

Electrode, Ion Specific, Calcium

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 IDK191360
510k NumberK191360
Device Name:I-STAT CHEM8+ Cartridge With The I-STAT 1 System
ClassificationElectrode, Ion Specific, Calcium
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 CodeJFP  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-21
Decision Date2020-02-14

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