Clearance Summary
REAGENT, LYSING AND HEMOGLOBIN received FDA 510(k) clearance under submission number K782098, sponsored by Dade, Baxter Travenol 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 1979-01-17.
- Submission: K782098
- Applicant / Sponsor: Dade, Baxter Travenol Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8540
- Decision date: 1979-01-17
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.