Clearance Summary
FRESH CELLS HFF received FDA 510(k) clearance under submission number K973214, sponsored by Diagnostic Hybrids, 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 1997-09-25.
- Submission: K973214
- Applicant / Sponsor: Diagnostic Hybrids, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2280
- Decision date: 1997-09-25
Classification & Regulation
This clearance is catalogued under FDA product code KIR and 21 CFR 864.2280, within the Hematology review panel as a Class I device.