i-STAT Hematocrit test with i-STAT Alinity System— 510(k) K163342

Name: FDA 510(k) clearance K163342
Creator: U.S. Food and Drug Administration
Published: 2017-08-22

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K163342 for i-STAT Hematocrit test with i-STAT Alinity System, Substantially Equivalent on 2017-08-22. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 2016-11-29
Decision date: 2017-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

Download summary PDF View on FDA.gov ↗

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