i-STAT TBI Cartridge with the i-STAT Alinity System— 510(k) K234143

Name: FDA 510(k) clearance K234143
Creator: U.S. Food and Drug Administration
Published: 2024-03-27

Substantially Equivalent

Abbott Point of Care

FDA 510(k) clearance K234143 for i-STAT TBI Cartridge with the i-STAT Alinity System, Substantially Equivalent on 2024-03-27. Applicant: Abbott Point of Care. Device class: 2.

Clearance details

Applicant: Abbott Point of Care
Product code: Code QAT
Device class: Class 2
Regulation: 21 CFR 866.5830
Advisory panel: Immunology
Date received: 2023-12-29
Decision date: 2024-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

Download summary PDF View on FDA.gov ↗

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DEN170045 — Banyan BTI2018-02-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.