Clearance Summary
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) received FDA 510(k) clearance under submission number K083716, sponsored by Church & Dwight Co., 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 2009-06-08.
- Submission: K083716
- Applicant / Sponsor: Church & Dwight Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2009-06-08
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.