EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL— 510(k) K130080

Name: FDA 510(k) clearance K130080
Creator: U.S. Food and Drug Administration
Published: 2014-05-13

Substantially Equivalent

Medica Corporation

FDA 510(k) clearance K130080 for EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL, Substantially Equivalent on 2014-05-13. Applicant: Medica Corporation. Device class: 2.

Clearance details

Applicant: Medica Corporation
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2013-01-14
Decision date: 2014-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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