Clearance Summary
WAMPOLE HS-CRP ELISA received FDA 510(k) clearance under submission number K011855, sponsored by Carter-Wallace, 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 2002-01-08.
- Submission: K011855
- Applicant / Sponsor: Carter-Wallace, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2002-01-08
Classification & Regulation
This clearance is catalogued under FDA product code DCN and 21 CFR 866.5270, within the Immunology review panel as a Class II device.