PATHFAST CK-MB-II CALIBRATORS— 510(k) K130628

Name: FDA 510(k) clearance K130628
Creator: U.S. Food and Drug Administration
Published: 2013-10-04

Substantially Equivalent

Mitsubishi Chemical Medience Corporation

FDA 510(k) clearance K130628 for PATHFAST CK-MB-II CALIBRATORS, Substantially Equivalent on 2013-10-04. Applicant: Mitsubishi Chemical Medience Corporation. Device class: 2.

Clearance details

Applicant: Mitsubishi Chemical Medience Corporation
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2013-03-08
Decision date: 2013-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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