HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER


information about

Device Classification Name

method, nephelometric, immunoglobulins (g, a, m)

510(k) Number K000701
Device Name HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
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 866.5510
Classification Product Code
CFN  
Date Received 03/01/2000
Decision Date 04/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No