Clearance Summary
MICROELISA MINIREADER II received FDA 510(k) clearance under submission number K830200, sponsored by Dynatech Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1983-02-16.
- Submission: K830200
- Applicant / Sponsor: Dynatech Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 1983-02-16
Classification & Regulation
This clearance is catalogued under FDA product code LBI and 21 CFR 880.5700, within the General Hospital review panel as a Class II device.