COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM— 510(k) K050821

Name: FDA 510(k) clearance K050821
Creator: U.S. Food and Drug Administration
Published: 2005-08-16

Substantially Equivalent

Zycare

FDA 510(k) clearance K050821 for COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM, Substantially Equivalent on 2005-08-16. Applicant: Zycare. Device class: 2.

Clearance details

Applicant: Zycare
Product code: Code KQG
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 2005-03-31
Decision date: 2005-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chapel Hill, NC, US

Download summary PDF View on FDA.gov ↗

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