BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL


Device Classification Name

multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus

510(k) Number K111072
Device Name BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
Applicant
Bio-Rad Laboratories
5500 e. 2nd street
benicia, 
CA 
94510

Applicant Contact juang wang
Correspondent
Bio-Rad Laboratories
5500 e. 2nd street
benicia, 
CA 
94510

Correspodent Contact juang wang
Regulation Number 866.3510
Classification Product Code
OPL  
Subsequent Product Codes
LFY   LJB   LJY  
Date Received 04/18/2011
Decision Date 08/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No