Device Classification Name |
plasma, coagulation control
|
510(k) Number |
K103313 |
Device Name |
HEPARIN ASSAY CONTROLS |
Applicant |
MEDTRONIC INC. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Applicant Contact |
JEFFREY L KOLL |
Correspondent |
MEDTRONIC INC. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Correspondent Contact |
JEFFREY L KOLL |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 11/10/2010 |
Decision Date | 12/01/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|