Clearance Summary
CHEMMATE SPECIAL STAIN LCA-CD45 received FDA 510(k) clearance under submission number K936111, sponsored by Biotek Solutions, 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 1996-02-27.
- Submission: K936111
- Applicant / Sponsor: Biotek Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 1996-02-27
Classification & Regulation
This clearance is catalogued under FDA product code DEH and 21 CFR 866.5550, within the Immunology review panel as a Class II device.