Clearance Summary
RAPI/TEX-LGM KIT received FDA 510(k) clearance under submission number K760673, sponsored by Hoechst-Roussel Pharmaceuticals, 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 1976-12-19.
- Submission: K760673
- Applicant / Sponsor: Hoechst-Roussel Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 1976-12-19
Classification & Regulation
This clearance is catalogued under FDA product code DFT and 21 CFR 866.5550, within the Immunology review panel as a Class II device.