Clearance Summary
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR received FDA 510(k) clearance under submission number K862506, sponsored by Millipore Corp.. 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 1986-07-29.
- Submission: K862506
- Applicant / Sponsor: Millipore Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1986-07-29
Classification & Regulation
This clearance is catalogued under FDA product code KIE and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.