Clearance Summary
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) received FDA 510(k) clearance under submission number K911912, sponsored by Serono-Baker Diagnostics, 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 1991-09-18.
- Submission: K911912
- Applicant / Sponsor: Serono-Baker Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1715
- Decision date: 1991-09-18
Classification & Regulation
This clearance is catalogued under FDA product code KHQ and 21 CFR 862.1715, within the Clinical Chemistry review panel as a Class II device.