Clearance Summary
ACTIM PROM received FDA 510(k) clearance under submission number K123986, sponsored by Alere Scarborough, 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 2014-01-09.
- Submission: K123986
- Applicant / Sponsor: Alere Scarborough, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1550
- Decision date: 2014-01-09
Classification & Regulation
This clearance is catalogued under FDA product code OAM and 21 CFR 862.1550, within the Clinical Chemistry review panel as a Class I device.