VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT— 510(k) K110880

Name: FDA 510(k) clearance K110880
Creator: U.S. Food and Drug Administration
Published: 2011-07-05

Substantially Equivalent

Maine Standards Company, LLC

FDA 510(k) clearance K110880 for VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT, Substantially Equivalent on 2011-07-05. Applicant: Maine Standards Company, LLC. Device class: 1.

Clearance details

Applicant: Maine Standards Company, LLC
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2011-03-30
Decision date: 2011-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, ME, US

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