Clearance Summary
HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- received FDA 510(k) clearance under submission number K810625, sponsored by Serono Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1981-03-27.
- Submission: K810625
- Applicant / Sponsor: Serono Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5065
- Decision date: 1981-03-27
Classification & Regulation
This clearance is catalogued under FDA product code DHI and 21 CFR 866.5065, within the Immunology review panel as a Class I device.