BIOPLEX VASCULITIS KIT


Device Classification Name

devices, measure, antibodies to glomerular basement membrane (gbm)

510(k) Number K072358
Device Name BIOPLEX VASCULITIS KIT
Applicant
Bio-Rad Laboratories
6565 185th ave, ne
redmond, 
WA 
98052

Applicant Contact priya bondre
Correspondent
Bio-Rad Laboratories
6565 185th ave, ne
redmond, 
WA 
98052

Correspodent Contact priya bondre
Regulation Number 866.5660
Classification Product Code
MVJ  
Subsequent Product Codes
JIX   JJY   MOB  
Date Received 08/22/2007
Decision Date 10/31/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No