Clearance Summary
MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL received FDA 510(k) clearance under submission number K881259, sponsored by Triton Biosciences, 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 1988-10-12.
- Submission: K881259
- Applicant / Sponsor: Triton Biosciences, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 1988-10-12
Classification & Regulation
This clearance is catalogued under FDA product code LYE and 21 CFR 866.5550, within the Immunology review panel as a Class II device.