Clearance Summary
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. received FDA 510(k) clearance under submission number K881138, sponsored by Baxter Healthcare Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1988-04-21.
- Submission: K881138
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1988-04-21
Classification & Regulation
This clearance is catalogued under FDA product code JMG and 21 CFR 866.5340, within the Immunology review panel as a Class II device.