Clearance Summary
ISOMUNE-CK received FDA 510(k) clearance under submission number K810905, sponsored by Hoffmann-La Roche, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1981-04-14.
- Submission: K810905
- Applicant / Sponsor: Hoffmann-La Roche, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1981-04-14
Classification & Regulation
This clearance is catalogued under FDA product code JHW and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.