Clearance Summary
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 received FDA 510(k) clearance under submission number K020758, sponsored by Pharmacia Deutschland GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-05-02.
- Submission: K020758
- Applicant / Sponsor: Pharmacia Deutschland GmbH
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2002-05-02
Classification & Regulation
This clearance is catalogued under FDA product code MID and 21 CFR 866.5660, within the Immunology review panel as a Class II device.