Clearance Summary
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis received FDA 510(k) clearance under submission number K170587, 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 2017-07-06.
- Submission: K170587
- Applicant / Sponsor: ACON Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1435
- Decision date: 2017-07-06
Classification & Regulation
This clearance is catalogued under FDA product code JIN and 21 CFR 862.1435, within the Clinical Chemistry review panel as a Class I device.