QRM — Multiple Use Blood Lancet For Multiple Patient Use Class III
FDA product code QRM covers "Multiple Use Blood Lancet For Multiple Patient Use", a Class III medical device regulated under 21 CFR 878.4850. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- QRM
- Device Class
- Class III
- Regulation Number
- 878.4850
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.