i-STAT CG8+ cartridge with the i-STAT 1 System— 510(k) K230300

Substantially Equivalent

Abbott Point of Care, Inc.

FDA 510(k) clearance K230300 for i-STAT CG8+ cartridge with the i-STAT 1 System, Substantially Equivalent on 2023-10-27. Applicant: Abbott Point of Care, Inc..

Clearance details

Applicant: Abbott Point of Care, Inc.
Product code: Code JFP
Advisory panel: Clinical Chemistry
Date received: 2023-02-03
Decision date: 2023-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

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