ELECSYS PROBNP IMMUNOASSAY


Device Classification Name

test,natriuretic peptide

510(k) Number K022516
Device Name ELECSYS PROBNP IMMUNOASSAY
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Original Contact robert a gregg
Regulation Number 862.1117
Classification Product Code
NBC  
Subsequent Product Codes
JIT   JJX  
Date Received 07/30/2002
Decision Date 11/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No