Clearance Summary
HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM received FDA 510(k) clearance under submission number K926114, sponsored by Tissue Culture Biotec, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1993-05-20.
- Submission: K926114
- Applicant / Sponsor: Tissue Culture Biotec, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1993-05-20
Classification & Regulation
This clearance is catalogued under FDA product code DHN and 21 CFR 866.5100, within the Immunology review panel as a Class II device.