i-STAT CHEM8+ cartridge with the i-STAT 1 System— 510(k) K191360

Name: FDA 510(k) clearance K191360
Creator: U.S. Food and Drug Administration
Published: 2020-02-14

Substantially Equivalent

Abbott Point of Care, Inc.

FDA 510(k) clearance K191360 for i-STAT CHEM8+ cartridge with the i-STAT 1 System, Substantially Equivalent on 2020-02-14. Applicant: Abbott Point of Care, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Point of Care, Inc.
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 2019-05-21
Decision date: 2020-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

Download summary PDF View on FDA.gov ↗

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