Clearance Summary
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT received FDA 510(k) clearance under submission number K882490, sponsored by R&D Systems, 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 1988-07-25.
- Submission: K882490
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8200
- Decision date: 1988-07-25
Classification & Regulation
This clearance is catalogued under FDA product code GIF and 21 CFR 864.8200, within the Hematology review panel as a Class I device.