Clearance Summary
QUANTRX FEMALE FERTILITY TEST received FDA 510(k) clearance under submission number K070484, sponsored by Quantrx Biomedical Corporation. 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 2007-10-22.
- Submission: K070484
- Applicant / Sponsor: Quantrx Biomedical Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1300
- Decision date: 2007-10-22
Classification & Regulation
This clearance is catalogued under FDA product code NGA and 21 CFR 862.1300, within the Clinical Chemistry review panel as a Class I device.