ELECSYS HSV-2 IGG IMMUNOASSAY


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K121895
Device Name ELECSYS HSV-2 IGG IMMUNOASSAY
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Applicant Contact k. colleen adams
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Correspodent Contact k. colleen adams
Regulation Number 862.1660
Classification Product Code
JJX  
Subsequent Product Code
MYF  
Date Received 06/29/2012
Decision Date 08/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No