Clearance Summary
HOSPITAL LAB IN-HOME EARLY PREG TEST received FDA 510(k) clearance under submission number K832593, sponsored by Aicl-Pack, 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 1984-01-11.
- Submission: K832593
- Applicant / Sponsor: Aicl-Pack, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1984-01-11
Classification & Regulation
This clearance is catalogued under FDA product code LCX and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.