Clearance Summary
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 received FDA 510(k) clearance under submission number K111335, 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 2011-12-01.
- Submission: K111335
- Applicant / Sponsor: Tosoh Bioscience, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1025
- Decision date: 2011-12-01
Classification & Regulation
This clearance is catalogued under FDA product code CKG and 21 CFR 862.1025, within the Clinical Chemistry review panel as a Class II device.