VALIDATE Heparin Calibration Verification/Linearity Test Kit— 510(k) K163498

Name: FDA 510(k) clearance K163498
Creator: U.S. Food and Drug Administration
Published: 2017-03-16

Substantially Equivalent

Maine Standards Company, LLC

FDA 510(k) clearance K163498 for VALIDATE Heparin Calibration Verification/Linearity Test Kit, Substantially Equivalent on 2017-03-16. Applicant: Maine Standards Company, LLC. Device class: 2.

Clearance details

Applicant: Maine Standards Company, LLC
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2016-12-13
Decision date: 2017-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland Foreside, ME, US

Download summary PDF View on FDA.gov ↗

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