K161521 is an FDA 510(k) clearance for the TAP Blood Collection Device. This device is classified as a Capillary Blood Collection Device For Alternative Site Collection (Class II - Special Controls, product code PRJ).
Submitted by Seventh Sense Biosystems, Inc. (Medford, US). The FDA issued a Cleared decision on February 16, 2017, 259 days after receiving the submission on June 2, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675. 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..
| 510(k) Number | K161521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2016 |
| Decision Date | February 16, 2017 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PRJ - Capillary Blood Collection Device For Alternative Site Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
| Definition | 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. |