VIDAS NT-PROBNP ASSAY, MODEL: 30 449


Device Classification Name

test,natriuretic peptide

510(k) Number K073091
Device Name VIDAS NT-PROBNP ASSAY, MODEL: 30 449
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Applicant Contact nikita s mapp
Correspondent
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Correspodent Contact nikita s mapp
Regulation Number 862.1117
Classification Product Code
NBC  
Date Received 11/01/2007
Decision Date 02/29/2008
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