Cleared Traditional

EXTENDSURE HBFASC CONTROL

K053031 · Cantebury Scientific , Ltd. · Hematology

Dec 2005

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K053031 is an FDA 510(k) clearance for the EXTENDSURE HBFASC CONTROL, a Control, Hemoglobin, Abnormal (Class II — Special Controls, product code JCM), submitted by Cantebury Scientific , Ltd. (Christchurch, Canterbury, NZ). The FDA issued a Cleared decision on December 7, 2005, 41 days after receiving the submission on October 27, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number	K053031 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2005
Decision Date	December 07, 2005
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF