Clearance Summary
AT HOME OVULATION TEST, MODEL 9032 received FDA 510(k) clearance under submission number K021409, sponsored by Phamatech, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2002-05-24.
- Submission: K021409
- Applicant / Sponsor: Phamatech, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 2002-05-24
Classification & Regulation
This clearance is catalogued under FDA product code CEP and 21 CFR 862.1485, within the Clinical Chemistry review panel as a Class I device.