TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200

Device Classification Name

test,natriuretic peptide

510(k) Number K033383
Device Name TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
Applicant
BIOSITE INCORPORATED
11030 roselle st.
san diego, 
CA 
92121

Applicant Contact jeffrey r dahlen, ph.d.
Correspondent
BIOSITE INCORPORATED
11030 roselle st.
san diego, 
CA 
92121

Correspodent Contact jeffrey r dahlen, ph.d.
Regulation Number 862.1117
Classification Product Code
NBC  
Subsequent Product Codes
JIT   JJX  
Date Received 10/23/2003
Decision Date 12/23/2003
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