Clearance Summary
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST received FDA 510(k) clearance under submission number K112449, sponsored by Tianjin New Bay Bioresearch 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 2012-09-24.
- Submission: K112449
- Applicant / Sponsor: Tianjin New Bay Bioresearch Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2012-09-24
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.