ELECSYS PROBNP II CALCHECK


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K080147
Device Name ELECSYS PROBNP II CALCHECK
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact kay a taylor
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact kay a taylor
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 01/22/2008
Decision Date 02/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No