PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M


Device Classification Name

antibody igm, if, epstein-barr virus

510(k) Number K073381
Device Name PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
Applicant
FOCUS DIAGNOSTICS, INC.
10703 progress way
cypress, 
CA 
90630 -4737

Applicant Contact constance bridges
Correspondent
FOCUS DIAGNOSTICS, INC.
10703 progress way
cypress, 
CA 
90630 -4737

Correspodent Contact constance bridges
Regulation Number 866.3235
Classification Product Code
LJN  
Date Received 12/03/2007
Decision Date 08/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No