Device Classification Name |
test, natriuretic peptide
|
510(k) Number |
K052789 |
Device Name |
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 |
Applicant |
BIOSITE INCORPORATED |
9975 Summers Ridge Road |
San Diego,
CA
92121
|
|
Applicant Contact |
RACHAEL S WILLIAMSON |
Correspondent |
BIOSITE INCORPORATED |
9975 Summers Ridge Road |
San Diego,
CA
92121
|
|
Correspondent Contact |
RACHAEL S WILLIAMSON |
Regulation Number | 862.1117
|
Classification Product Code |
|
Date Received | 10/03/2005 |
Decision Date | 01/23/2006 |
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
|
|
|