Clearance Summary
HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN received FDA 510(k) clearance under submission number K834117, 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 1984-03-22.
- Submission: K834117
- Applicant / Sponsor: Bartels Immunodiagnostic Supplies, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2280
- Decision date: 1984-03-22
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.