AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA


Device Classification Name

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

510(k) Number K022945
Device Name AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
Original Applicant
HYCOR BIOMEDICAL, INC.
7272 chapman ave.
garden grove, 
CA 
92841

Original Contact randy wilson
Regulation Number 866.5660
Classification Product Code
MSV  
Date Received 09/05/2002
Decision Date 12/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No