HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)


Device Classification Name

control, hemoglobin, abnormal

510(k) Number K011389
Device Name HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
Original Applicant
CANTERBURY HEALTH LABORATORIES
hagley avenue
christchurch, canterbury, 

NZ

Original Contact maurice owen
Regulation Number 864.7415
Classification Product Code
JCM  
Date Received 05/07/2001
Decision Date 06/21/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No