i-STAT Crea cartridge with the i-STAT 1 System— 510(k) K261039

Name: FDA 510(k) clearance K261039
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Substantially Equivalent

Abbott Point of Care, Inc.

FDA 510(k) clearance K261039 for i-STAT Crea cartridge with the i-STAT 1 System, Substantially Equivalent on 2026-06-26. Applicant: Abbott Point of Care, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Point of Care, Inc.
Product code: Code CGL
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2026-03-30
Decision date: 2026-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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