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

Substantially Equivalent

Abbott Point of Care, Inc.

Clearance details

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

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