Clearance Summary
LACTOFERRIN MICROASSAY SYSTEM received FDA 510(k) clearance under submission number K934473, sponsored by Touch Scientific, 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 1993-12-03.
- Submission: K934473
- Applicant / Sponsor: Touch Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5570
- Decision date: 1993-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DEG and 21 CFR 866.5570, within the Immunology review panel as a Class I device.