CAPILLARYS URINE


Device Classification Name

immunochemical, bence-jones protein

510(k) Number K080916
Device Name CAPILLARYS URINE
Applicant
SEBIA
400-1705 corporate drive
suite 400
norcross, 
GA 
30093

Applicant Contact karen anderson
Correspondent
SEBIA
400-1705 corporate drive
suite 400
norcross, 
GA 
30093

Correspodent Contact karen anderson
Regulation Number 866.5150
Classification Product Code
JKM  
Date Received 04/02/2008
Decision Date 07/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No