Clearance Summary
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION received FDA 510(k) clearance under submission number K100464, 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 2011-02-23.
- Submission: K100464
- Applicant / Sponsor: Wako Chemicals USA, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6030
- Decision date: 2011-02-23
Classification & Regulation
This clearance is catalogued under FDA product code NSF and 21 CFR 866.6030, within the Immunology review panel as a Class II device.