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FDA 510(k)

i-STAT TBI Plasma cartridge with the i-STAT Alinity System

K-Number: K201778 · 2021-01-08

ApplicantAbbott Laboratories
Decision Date2021-01-08
Product CodeQAT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

i-STAT TBI Plasma cartridge with the i-STAT Alinity System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K201778. 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 Plasma cartridge with the i-STAT Alinity System?

i-STAT TBI Plasma cartridge with the i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Abbott Laboratories. The 510(k) number is K201778.

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

i-STAT TBI Plasma cartridge with the i-STAT Alinity System received FDA 510(k) clearance on 2021-01-08, under 510(k) number K201778.

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

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 i-STAT TBI Plasma cartridge with the i-STAT Alinity System?

The FDA product code for i-STAT TBI Plasma 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 Laboratories as applicant

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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 LaboratoriesK223602Traumatic brain injury (TBI) testAbbott 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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