Device Classification Name |
system, multipurpose for in vitro coagulation studies
|
510(k) Number |
K051030 |
Device Name |
COAG-A-MATE MTX III |
Applicant |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Applicant Contact |
JOHN CUSACK |
Correspondent |
BIOMERIEUX, INC. |
100 RODOLPHE ST |
DURHAM,
NC
27712
|
|
Correspondent Contact |
JOHN CUSACK |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 04/22/2005 |
Decision Date | 12/23/2005 |
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
|
|
|