Device Classification Name |
Capillary Blood Collection Device For Alternative Site Collection
|
510(k) Number |
K190225 |
Device Name |
TAP Blood Collection Device |
Applicant |
Seventh Sense Biosystems, Inc. |
200 Boston Avenue, Suite 3700 |
Medford,
MA
02155
|
|
Applicant Contact |
Tim Richards |
Correspondent |
Seventh Sense Biosystems, Inc. |
200 Boston Avenue, Suite 3700 |
Medford,
MA
02155
|
|
Correspondent Contact |
Tim Richards |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 02/05/2019 |
Decision Date | 11/05/2019 |
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
|
|
|