Clearance Summary
CODE QAS 103 ANTI-DNA CONTROLS received FDA 510(k) clearance under submission number K791354, sponsored by Amersham Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1979-09-17.
- Submission: K791354
- Applicant / Sponsor: Amersham Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1979-09-17
Classification & Regulation
This clearance is catalogued under FDA product code KTL and 21 CFR 866.5100, within the Immunology review panel as a Class II device.