BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT


Device Classification Name

antimitochondrial antibody, indirect immunofluorescent, antigen, control

510(k) Number K030238
Device Name BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
Original Applicant
THE BINDING SITE, LTD.
west tower, suite 4000
2425 west olympic boulevard
santa monica, 
CA 
90404

Original Contact jay h geller
Regulation Number 866.5090
Classification Product Code
DBM  
Date Received 01/23/2003
Decision Date 03/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No