Alinity c ICT Sample Diluent— 510(k) K170320

Name: FDA 510(k) clearance K170320
Creator: U.S. Food and Drug Administration
Published: 2017-10-24

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K170320 for Alinity c ICT Sample Diluent, Substantially Equivalent on 2017-10-24. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CGZ
Device class: Class 2
Regulation: 21 CFR 862.1170
Advisory panel: Clinical Chemistry
Date received: 2017-02-01
Decision date: 2017-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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