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FDA 510(k)

Traumatic brain injury (TBI) test

K-Number: K223602 · 2023-03-02

ApplicantAbbott Laboratories
Decision Date2023-03-02
Product CodeQAT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Traumatic brain injury (TBI) test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223602. 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 Traumatic brain injury (TBI) test?

Traumatic brain injury (TBI) test is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Abbott Laboratories. The 510(k) number is K223602.

When did Traumatic brain injury (TBI) test receive FDA 510(k) clearance?

Traumatic brain injury (TBI) test received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223602.

Who is the listed applicant for Traumatic brain injury (TBI) test?

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

What is the FDA product code for Traumatic brain injury (TBI) test?

The FDA product code for Traumatic brain injury (TBI) test is QAT.

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Related PubMed Literature

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.

PMID: 28363253The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration To Accelerate Diagnosis and Treatment of Traumatic Brain Injury.Journal of neurotrauma (2017)

Other records listing Abbott Laboratories 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.

PMA P120008KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSK252424Anti-HCV NextPMA P910007Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P980007Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditionsK243500ARCHITECT iGentamicinK243168Alinity i Rubella IgG

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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.K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of CareK232669TBIAbbott 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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