Clearance Summary
SERONORM LIPID received FDA 510(k) clearance under submission number K771437, sponsored by Nyegaard & Co. A/S. 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 1977-09-02.
- Submission: K771437
- Applicant / Sponsor: Nyegaard & Co. A/S
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1977-09-02
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.