Clearance Summary
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA received FDA 510(k) clearance under submission number K083878, sponsored by R2 Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2010-06-25.
- Submission: K083878
- Applicant / Sponsor: R2 Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8950
- Decision date: 2010-06-25
Classification & Regulation
This clearance is catalogued under FDA product code GIR and 21 CFR 864.8950, within the Hematology review panel as a Class I device.