DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA


Device Classification Name

test,natriuretic peptide

510(k) Number K080578
Device Name DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
Applicant
Siemens Healthcare Diagnostics Inc.
po box 6101
mailbox 514
newark, 
DE 
19714 -6101

Applicant Contact victor m carrio
Correspondent
Siemens Healthcare Diagnostics Inc.
po box 6101
mailbox 514
newark, 
DE 
19714 -6101

Correspodent Contact victor m carrio
Regulation Number 862.1117
Classification Product Code
NBC  
Subsequent Product Code
JIT  
Date Received 03/03/2008
Decision Date 05/16/2008
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