TAP Blood Collection Device
FDA 510(k) clearance K161521 · decided 2017-02-16
Clearance details
- K-number
- K161521
- Device name
- TAP Blood Collection Device
- Applicant
- Seventh Sense Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-02
- Decision date
- 2017-02-16
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- PRJ
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Medford, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Seventh Sense Biosystems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TAP Blood Collection Device (K190225) | Seventh Sense Biosystems, Inc. | 2019-11-05 |
Recalls involving this device
No recalls on record reference this clearance.