EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT— 510(k) K111036

Name: FDA 510(k) clearance K111036
Creator: U.S. Food and Drug Administration
Published: 2011-07-12

Substantially Equivalent

Medica Corporation

FDA 510(k) clearance K111036 for EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT, Substantially Equivalent on 2011-07-12. Applicant: Medica Corporation. Device class: 1.

Clearance details

Applicant: Medica Corporation
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2011-04-14
Decision date: 2011-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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