Clearance Summary
PREGNANCY ONE STEP RAPID TEST received FDA 510(k) clearance under submission number K103574, sponsored by Lehnus & Associates Consulting. 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 2011-07-28.
- Submission: K103574
- Applicant / Sponsor: Lehnus & Associates Consulting
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2011-07-28
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.