Clearance Summary
INSTANT-VIEW LH OVULATION PREDICTING TEST received FDA 510(k) clearance under submission number K022829, sponsored by Alfa Scientific Designs, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2002-11-05.
- Submission: K022829
- Applicant / Sponsor: Alfa Scientific Designs, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 2002-11-05
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.