Clearance Summary
Distinct® Early Detection Pregnancy Test received FDA 510(k) clearance under submission number K193318, sponsored by ACON Laboratories, 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 2020-08-20.
- Submission: K193318
- Applicant / Sponsor: ACON Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2020-08-20
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.