GEM PREMIER 4000— 510(k) K112995

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K112995 for GEM PREMIER 4000, Substantially Equivalent on 2012-05-03. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2011-10-07
Decision date: 2012-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, 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.