DeviceClearance

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

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.

Clearance details

Applicant
Abbott Point of Care
Product code
Code QAT
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Princton, NJ, US
Download summary PDFView on FDA.gov ↗

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