Clearance Summary
LYSING & HEMOGLOBIN REAGENT received FDA 510(k) clearance under submission number K841800, sponsored by Reagent Laboratory, 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 1984-05-31.
- Submission: K841800
- Applicant / Sponsor: Reagent Laboratory, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8540
- Decision date: 1984-05-31
Classification & Regulation
This clearance is catalogued under FDA product code GGK and 21 CFR 864.8540, within the Hematology review panel as a Class I device.