Clearance Summary
RAICHEM(TM) SPIA(TM) IGG REAGENTS received FDA 510(k) clearance under submission number K894416, sponsored by Reagents Applications, 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 1989-08-01.
- Submission: K894416
- Applicant / Sponsor: Reagents Applications, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5530
- Decision date: 1989-08-01
Classification & Regulation
This clearance is catalogued under FDA product code KTO and 21 CFR 866.5530, within the Immunology review panel as a Class I device.