GEM Premier ChemSTAT— 510(k) K183555

Name: FDA 510(k) clearance K183555
Creator: U.S. Food and Drug Administration
Published: 2019-02-16

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K183555 for GEM Premier ChemSTAT, Substantially Equivalent on 2019-02-16. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2018-12-20
Decision date: 2019-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.