Clearance Summary
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance under submission number K896145, 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 1989-12-27.
- Submission: K896145
- 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: 1989-12-27
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.