Clearance Summary
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 received FDA 510(k) clearance under submission number K990138, sponsored by Diagnostic Systems Laboratories, 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 1999-06-21.
- Submission: K990138
- Applicant / Sponsor: Diagnostic Systems Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1999-06-21
Classification & Regulation
This clearance is catalogued under FDA product code LOJ and 21 CFR 866.6010, within the Immunology review panel as a Class II device.