510(k) K161521
K161521 is an FDA 510(k) premarket notification submitted by Seventh Sense Biosystems, Inc. for the device "TAP Blood Collection Device". The FDA issued a decision of Substantially Equivalent on February 16, 2017. The device falls under product code PRJ (Capillary Blood Collection Device For Alternative Site Collection), a Class II device regulated under 21 CFR 862.1675. Seventh Sense Biosystems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2017
- Date Received
- June 2, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Capillary Blood Collection Device For Alternative Site Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.