Clearance Summary
AQUALITE INTACT PTH received FDA 510(k) clearance under submission number K970483, sponsored by Sealite Sciences, 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 1997-04-14.
- Submission: K970483
- Applicant / Sponsor: Sealite Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1545
- Decision date: 1997-04-14
Classification & Regulation
This clearance is catalogued under FDA product code CEW and 21 CFR 862.1545, within the Clinical Chemistry review panel as a Class II device.