Clearance Summary
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) received FDA 510(k) clearance under submission number K912318, 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 1991-07-25.
- Submission: K912318
- Applicant / Sponsor: Serono-Baker Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1260
- Decision date: 1991-07-25
Classification & Regulation
This clearance is catalogued under FDA product code CHP and 21 CFR 862.1260, within the Clinical Chemistry review panel as a Class I device.