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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care. It received FDA 510(k) clearance on 2024-03-27 under 510(k) 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. The listed applicant is Abbott Point of Care. The 510(k) number is K234143.

When did i-STAT TBI Cartridge with the i-STAT Alinity System receive FDA 510(k) clearance?

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

Who is the listed applicant for i-STAT TBI Cartridge with the i-STAT Alinity System?

The FDA 510(k) record lists Abbott Point of Care as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07373509Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood TestRECRUITING

Other records listing Abbott Point of Care as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261039i-STAT Crea cartridge with the i-STAT 1 SystemK253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemK240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemK230300i-STAT CG8+ cartridge with the i-STAT 1 SystemK230285i-STAT CG8+ cartridge with the i-STAT 1 System

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Related Devices (Code: QAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240279VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc.K232669TBIAbbott LaboratoriesK223602Traumatic brain injury (TBI) testAbbott LaboratoriesK201778i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemAbbott Laboratories

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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