510(k) K161521
- Device
- TAP Blood Collection Device
- Applicant
- Seventh Sense Biosystems, Inc.
- 510(k) number
- K161521
- Product code
- PRJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-16
- Date received
- 2016-06-02
- Regulation
- 862.1675
- Classification name
- Capillary Blood Collection Device For Alternative Site Collection
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIM RICHARDS
- Address
- 200 Boston Ave. Suite 3700 Medford MA US 02155 02155
FDA Registration Numbers#
- 1058584
- 2219920
Source Documents#
Other 510(k) Records For Product Code PRJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190225 | TAP Blood Collection Device | Seventh Sense Biosystems, Inc. | 2019-11-05 |
Legacy Summary#
summary
FDA Review#
Decision Summary