Clearance Summary
DYNABEADS HLA CELL PREP II ISOLATION PRODUCT received FDA 510(k) clearance under submission number K873185, sponsored by Dynal Biotech, 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 1987-11-04.
- Submission: K873185
- Applicant / Sponsor: Dynal Biotech, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8500
- Decision date: 1987-11-04
Classification & Regulation
This clearance is catalogued under FDA product code JCF and 21 CFR 864.8500, within the Hematology review panel as a Class I device.