Clearance Summary
CELL-CULTURE SHAKER received FDA 510(k) clearance under submission number K881466, sponsored by Cryodyne Technologies, 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 1988-04-18.
- Submission: K881466
- Applicant / Sponsor: Cryodyne Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1988-04-18
Classification & Regulation
This clearance is catalogued under FDA product code KJB and 21 CFR 864.2240, within the Hematology review panel as a Class I device.