Clearance Summary
DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST received FDA 510(k) clearance under submission number K852286, sponsored by Sero-Immuno Diagnostics, 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 1985-07-09.
- Submission: K852286
- Applicant / Sponsor: Sero-Immuno Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1985-07-09
Classification & Regulation
This clearance is catalogued under FDA product code JHJ and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.