CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM


Device Classification Name

abnormal hemoglobin quantitation

510(k) Number K112550
Device Name CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
Applicant
SEBIA
400-1705 corporate drive
norcross, 
GA 
30096

Applicant Contact karen anderson
Correspondent
SEBIA
400-1705 corporate drive
norcross, 
GA 
30096

Correspodent Contact karen anderson
Regulation Number 864.7415
Classification Product Code
GKA  
Date Received 09/01/2011
Decision Date 05/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No