Clearance Summary
HOME PREGNANCY TEST received FDA 510(k) clearance under submission number K112315, sponsored by Newscen Coast Bio-Pharmaceutical Co., Ltd.. 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 2012-04-23.
- Submission: K112315
- Applicant / Sponsor: Newscen Coast Bio-Pharmaceutical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2012-04-23
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.