EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475— 510(k) K100060

Name: FDA 510(k) clearance K100060
Creator: U.S. Food and Drug Administration
Published: 2010-12-15

Substantially Equivalent

Vital Diagnostics (Manufacturing) Ptyltd

FDA 510(k) clearance K100060 for EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475, Substantially Equivalent on 2010-12-15. Applicant: Vital Diagnostics (Manufacturing) Ptyltd. Device class: 2.

Clearance details

Applicant: Vital Diagnostics (Manufacturing) Ptyltd
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2010-01-11
Decision date: 2010-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noble Park, AU

Download summary PDF View on FDA.gov ↗

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