Multiple Use Blood Lancet For Single Patient Use Only
QRL · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4850
Classification
FDA Product Code
QRL
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4850
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A multiple use capable blood lancet intended for use on a single patient 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.