ARKIT HBA1C


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K030553
Device Name ARKIT HBA1C
Applicant
ARKRAY, INC.
2320 scientific park dr.
wilmington, 
NC 
28405

Applicant Contact gary m haight
Correspondent
ARKRAY, INC.
2320 scientific park dr.
wilmington, 
NC 
28405

Correspodent Contact gary m haight
Regulation Number 864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJX  
Date Received 02/21/2003
Decision Date 09/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No