PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G


Device Classification Name

epstein-barr virus, other

510(k) Number K073382
Device Name PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
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
LSE  
Date Received 12/03/2007
Decision Date 07/28/2008
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