Clearance Summary
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 received FDA 510(k) clearance under submission number K062368, sponsored by Wako Chemicals USA, 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 2007-01-31.
- Submission: K062368
- Applicant / Sponsor: Wako Chemicals USA, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6030
- Decision date: 2007-01-31
Classification & Regulation
This clearance is catalogued under FDA product code OAU and 21 CFR 866.6030, within the Immunology review panel as a Class II device.