i-STAT TBI Plasma cartridge with the i-STAT Alinity System— 510(k) K201778

Name: FDA 510(k) clearance K201778
Creator: U.S. Food and Drug Administration
Published: 2021-01-08

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K201778 for i-STAT TBI Plasma cartridge with the i-STAT Alinity System, Substantially Equivalent on 2021-01-08. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code QAT
Device class: Class 2
Regulation: 21 CFR 866.5830
Advisory panel: Immunology
Date received: 2020-06-30
Decision date: 2021-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

Download summary PDF View on FDA.gov ↗

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