Clearance Summary
ORTHO* SERUM ELISA TEST SYSTEM received FDA 510(k) clearance under submission number K833636, sponsored by Ortho Diagnostic Systems, 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 1984-06-13.
- Submission: K833636
- Applicant / Sponsor: Ortho Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5240
- Decision date: 1984-06-13
Classification & Regulation
This clearance is catalogued under FDA product code DAK and 21 CFR 866.5240, within the Immunology review panel as a Class II device.