AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA


Device Classification Name

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

510(k) Number K030397
Device Name AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
Applicant
HYCOR BIOMEDICAL LTD.
pentlands science park
bush loan
edinburgh, 

GB

eh26 opl

Applicant Contact danielle m knight
Correspondent
HYCOR BIOMEDICAL LTD.
pentlands science park
bush loan
edinburgh, 

GB

eh26 opl

Correspodent Contact danielle m knight
Regulation Number 866.5660
Classification Product Code
MSV  
Date Received 02/06/2003
Decision Date 03/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No