Device |
single use only blood lancet without an integral sharps injury prevention feature |
Definition |
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. |
Physical State |
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base. |
Technical Method |
Used to puncture the skin. |
Target Area |
Skin. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | QRK |
Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4850
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |