Clearance Summary
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 received FDA 510(k) clearance under submission number K040452, 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 2004-05-11.
- Submission: K040452
- Applicant / Sponsor: Pharmacia Deutschland GmbH
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2004-05-11
Classification & Regulation
This clearance is catalogued under FDA product code MSV and 21 CFR 866.5660, within the Immunology review panel as a Class II device.