I-STAT TBI Plasma Cartridge With The I-STAT Alinity System

Brain Trauma Assessment Test

Abbott Laboratories

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for I-stat Tbi Plasma Cartridge With The I-stat Alinity System.

Pre-market Notification Details

Device IDK201778
510k NumberK201778
Device Name:I-STAT TBI Plasma Cartridge With The I-STAT Alinity System
ClassificationBrain Trauma Assessment Test
Applicant Abbott Laboratories 400 College Road East Princeton,  NJ  08540
ContactBrian Ma
CorrespondentBrian Ma
Abbott Laboratories 400 College Road East Princeton,  NJ  08540
Product CodeQAT  
CFR Regulation Number866.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-30
Decision Date2021-01-08

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