ELECSYS RUBELLA IGG IMMUNOASSAY


Device Classification Name

enzyme linked immunoabsorbent assay, rubella

510(k) Number K072617
Device Name ELECSYS RUBELLA IGG IMMUNOASSAY
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact theresa a bush
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact theresa a bush
Regulation Number 866.3510
Classification Product Code
LFX  
Subsequent Product Code
JJX  
Date Received 09/17/2007
Decision Date 12/05/2008
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