BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.


Device Classification Name

system,test,antibodies,b2 – glycoprotein i (b2 – gpi)

510(k) Number K991804
Device Name BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
Applicant
THE BINDING SITE, LTD.
east tower, suite 600
2425 west olympic boulevard
santa monica, 
CA 
90404

Applicant Contact jay h geller
Correspondent
THE BINDING SITE, LTD.
east tower, suite 600
2425 west olympic boulevard
santa monica, 
CA 
90404

Correspodent Contact jay h geller
Regulation Number 866.5660
Classification Product Code
MSV  
Date Received 05/26/1999
Decision Date 05/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No