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U.S. Department of Health and Human Services

Product Classification
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Device single use only blood lancet without an integral sharps injury prevention feature
Regulation Description Blood lancets.
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 CodeQRK
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
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