Clearance Summary
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 received FDA 510(k) clearance under submission number K023433, sponsored by Pharmacia Diagnostics GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-11-13.
- Submission: K023433
- Applicant / Sponsor: Pharmacia Diagnostics GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2002-11-13
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.