BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS


Device Classification Name

system, test, anticardiolipin immunological

510(k) Number K103834
Device Name BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
Applicant
Bio-Rad Laboratories
bioplex 2200 division
5500 east second st
benicia, 
CA 
94510

Applicant Contact juang wang
Correspondent
Bio-Rad Laboratories
bioplex 2200 division
5500 east second st
benicia, 
CA 
94510

Correspodent Contact juang wang
Regulation Number 866.5660
Classification Product Code
MID  
Subsequent Product Codes
JIX   JJX   MSV  
Date Received 12/30/2010
Decision Date 03/30/2012
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