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FDA 510(k)

i-STAT TBI Cartridge with the i-STAT Alinity System

K-Number: K234143 · 2024-03-27

ApplicantAbbott Point of Care
Decision Date2024-03-27
Product CodeQAT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

i-STAT TBI Cartridge with the i-STAT Alinity System is a medical device manufactured by Abbott Point of Care. It received FDA 510(k) clearance on 2024-03-27 under approval number K234143. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-STAT TBI Cartridge with the i-STAT Alinity System?

i-STAT TBI Cartridge with the i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2024-03-27. It is manufactured by Abbott Point of Care. The 510(k) number is K234143.

When was i-STAT TBI Cartridge with the i-STAT Alinity System approved by the FDA?

i-STAT TBI Cartridge with the i-STAT Alinity System received FDA 510(k) clearance on 2024-03-27, under approval number K234143.

What company makes i-STAT TBI Cartridge with the i-STAT Alinity System?

i-STAT TBI Cartridge with the i-STAT Alinity System is manufactured by Abbott Point of Care.

What is the FDA product code for i-STAT TBI Cartridge with the i-STAT Alinity System?

The FDA product code for i-STAT TBI Cartridge with the i-STAT Alinity System is QAT.

Related Clinical Trials

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Related Devices (Code: QAT)

DEN170045Banyan BTIBanyan Biomarkers, Inc. K201778i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories K232669TBIAbbott Laboratories K223602Traumatic brain injury (TBI) testAbbott Laboratories K240279VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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