Cleared Traditional

HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)

K011389 · Canterbury Health Laboratories · Hematology

Jun 2001

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K011389 is an FDA 510(k) clearance for the HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL), a Control, Hemoglobin, Abnormal (Class II — Special Controls, product code JCM), submitted by Canterbury Health Laboratories (Christchurch, Canterbury, NZ). The FDA issued a Cleared decision on June 21, 2001, 45 days after receiving the submission on May 7, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number	K011389 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 2001
Decision Date	June 21, 2001
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF