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
|
|
Correspondent Contact |
JEFFREY R DAHLEN, PH.D. |
Regulation Number | 862.1117
|
Classification Product Code |
|
Subsequent Product Codes |
|
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
|
Recalls |
CDRH Recalls
|
|
|