Clearance Summary
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 received FDA 510(k) clearance under submission number K050713, sponsored by Good Biotech Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2005-06-06.
- Submission: K050713
- Applicant / Sponsor: Good Biotech Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2005-06-06
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.