TAP Blood Collection Device
FDA 510(k) clearance K190225 · decided 2019-11-05
Clearance details
- K-number
- K190225
- Device name
- TAP Blood Collection Device
- Applicant
- Seventh Sense Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-05
- Decision date
- 2019-11-05
- Days to decision
- 273 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
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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 (K161521) | Seventh Sense Biosystems, Inc. | 2017-02-16 |
Recalls involving this device
No recalls on record reference this clearance.