Clearance Summary
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set received FDA 510(k) clearance under submission number K143075, sponsored by Tosoh Bioscience, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2015-07-02.
- Submission: K143075
- Applicant / Sponsor: Tosoh Bioscience, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1680
- Decision date: 2015-07-02
Classification & Regulation
This clearance is catalogued under FDA product code CDZ and 21 CFR 862.1680, within the Clinical Chemistry review panel as a Class I device.