Device Classification Name |
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
|
510(k) Number |
K040437 |
Device Name |
TRIAGE PROFILER S.O.B. PANEL |
Applicant |
BIOSITE INCORPORATED |
11030 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
JEFFREY R DAHLEN |
Correspondent |
BIOSITE INCORPORATED |
11030 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
JEFFREY R DAHLEN |
Regulation Number | 864.7320
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/19/2004 |
Decision Date | 06/25/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|