HEMOGLOBIN A1C CONTROL


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K021484
Device Name HEMOGLOBIN A1C CONTROL
Original Applicant
CANTERBURY SCIENTIFIC LTD.
21 wroxton terrace
christchurch, 

NZ

Original Contact maurice owen
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 05/08/2002
Decision Date 06/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No