Device Classification Name |
Fibrin Split Products
|
510(k) Number |
K042890 |
Device Name |
TRIAGE D-DIMER TEST, MODEL 98100 |
Applicant |
BIOSITE INCORPORATED |
11030 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
JEFFERY R DAHLEN |
Correspondent |
BIOSITE INCORPORATED |
11030 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
JEFFERY R DAHLEN |
Regulation Number | 864.7320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/19/2004 |
Decision Date | 11/29/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|