510(k) K810681
K810681 is an FDA 510(k) premarket notification submitted by Medicore, Inc. for the device "MEDI-LANCE". The FDA issued a decision of Substantially Equivalent on Mar 26, 1981. The device falls under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850. Medicore, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 26, 1981
- Date Received
- Mar 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device Class
- Class II
- Regulation Number
- 878.4850
- Review Panel
- SU
- Submission Type
- 510(k)
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.