Clearance Summary
AGGLUTEX MORPHINE TEST KIT received FDA 510(k) clearance under submission number K812985, sponsored by Hoffmann-La Roche, 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 1981-12-31.
- Submission: K812985
- Applicant / Sponsor: Hoffmann-La Roche, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5735
- Decision date: 1981-12-31
Classification & Regulation
This clearance is catalogued under FDA product code DDF and 21 CFR 866.5735, within the Immunology review panel as a Class I device.