Clearance Summary
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE received FDA 510(k) clearance under submission number K880388, sponsored by Serono 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 1988-03-03.
- Submission: K880388
- Applicant / Sponsor: Serono Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1710
- Decision date: 1988-03-03
Classification & Regulation
This clearance is catalogued under FDA product code CDP and 21 CFR 862.1710, within the Clinical Chemistry review panel as a Class II device.