Cleared Traditional

COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM

K050821 · Zycare · Hematology

Aug 2005

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K050821 is an FDA 510(k) clearance for the COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM, a Instrument, Coagulation (Class II — Special Controls, product code KQG), submitted by Zycare (Chapel Hill, US). The FDA issued a Cleared decision on August 16, 2005, 138 days after receiving the submission on March 31, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number	K050821 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2005
Decision Date	August 16, 2005
Days to Decision	138 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF