Clearance Summary
PHASE II HCG KIT received FDA 510(k) clearance under submission number K840328, sponsored by Medical & Scientific Designs, 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 1984-04-19.
- Submission: K840328
- Applicant / Sponsor: Medical & Scientific Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1984-04-19
Classification & Regulation
This clearance is catalogued under FDA product code JHI and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.