i-STAT CHEM8+ cartridge with the i-STAT 1 System— 510(k) K191298

Name: FDA 510(k) clearance K191298
Creator: U.S. Food and Drug Administration
Published: 2020-02-07

Substantially Equivalent

Abbott Point of Care, Inc.

FDA 510(k) clearance K191298 for i-STAT CHEM8+ cartridge with the i-STAT 1 System, Substantially Equivalent on 2020-02-07. Applicant: Abbott Point of Care, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Point of Care, Inc.
Product code: Code JFL
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2019-05-14
Decision date: 2020-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

Download summary PDF View on FDA.gov ↗

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