PRJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Capillary Blood Collection Device For Alternative Site Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Medical specialty
- Clinical Chemistry
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| TAP Blood Collection Device (K190225) | Seventh Sense Biosystems, Inc. | 2019-11-05 |
| TAP Blood Collection Device (K161521) | Seventh Sense Biosystems, Inc. | 2017-02-16 |
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