ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET


Device Classification Name

test,natriuretic peptide

510(k) Number K072437
Device Name ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Applicant Contact kay taylor
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Correspodent Contact kay taylor
Regulation Number 862.1117
Classification Product Code
NBC  
Subsequent Product Codes
JIT   JJY  
Date Received 08/23/2007
Decision Date 02/05/2008
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