TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST


Device Classification Name

test,natriuretic peptide

510(k) Number K021317
Device Name TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
Original Applicant
BIOSITE INCORPORATED
11030 roselle st.
san diego, 
CA 
92121

Original Contact jeffery r dahlen
Regulation Number 862.1117
Classification Product Code
NBC  
Date Received 04/25/2002
Decision Date 07/01/2002
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