SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2


Device Classification Name

abnormal hemoglobin quantitation

510(k) Number K112491
Device Name SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
Applicant
SEBIA
parc technologique leonard de
vinci
evry, 

FR

91008

Applicant Contact karen anderson
Correspondent
SEBIA
parc technologique leonard de
vinci
evry, 

FR

91008

Correspodent Contact karen anderson
Regulation Number 864.7415
Classification Product Code
GKA  
Date Received 08/29/2011
Decision Date 05/24/2012
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