EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES— 510(k) K090734

Name: FDA 510(k) clearance K090734
Creator: U.S. Food and Drug Administration
Published: 2009-07-17

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K090734 for EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES, Substantially Equivalent on 2009-07-17. Applicant: Medica Corp.. Device class: 1.

Clearance details

Applicant: Medica Corp.
Product code: Code MRR
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2009-03-19
Decision date: 2009-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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