VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT


Device Classification Name

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

510(k) Number K992224
Device Name VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
Applicant
HEMAGEN DIAGNOSTICS, INC.
40 bear hill rd.
waltham, 
MA 
02451

Applicant Contact joseph m califano
Correspondent
HEMAGEN DIAGNOSTICS, INC.
40 bear hill rd.
waltham, 
MA 
02451

Correspodent Contact joseph m califano
Regulation Number 866.5660
Classification Product Code
MSV  
Date Received 07/01/1999
Decision Date 08/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No