Clearance Summary
GRAMSTAIN SET received FDA 510(k) clearance under submission number K821977, sponsored by Granite 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 1982-07-22.
- Submission: K821977
- Applicant / Sponsor: Granite Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1982-07-22
Classification & Regulation
This clearance is catalogued under FDA product code HYI and 21 CFR 864.1850, within the Hematology review panel as a Class I device.