Clearance Summary
HEP-2 CELLS received FDA 510(k) clearance under submission number K842834, sponsored by Bartels Immunodiagnostic Supplies, 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 1984-08-28.
- Submission: K842834
- Applicant / Sponsor: Bartels Immunodiagnostic Supplies, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1984-08-28
Classification & Regulation
This clearance is catalogued under FDA product code KJR and 21 CFR 864.1850, within the Hematology review panel as a Class I device.