Clearance Summary
ASTROSCAN 2100 MICROTITER PLATE READER received FDA 510(k) clearance under submission number K881458, sponsored by Astroscan , Ltd.. 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 1988-06-29.
- Submission: K881458
- Applicant / Sponsor: Astroscan , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1988-06-29
Classification & Regulation
This clearance is catalogued under FDA product code JJQ and 21 CFR 862.2300, within the Clinical Chemistry review panel as a Class I device.