Clearance Summary
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET received FDA 510(k) clearance under submission number K121533, 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 2012-06-15.
- Submission: K121533
- Applicant / Sponsor: Tosoh Bioscience, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1377
- Decision date: 2012-06-15
Classification & Regulation
This clearance is catalogued under FDA product code LPS and 21 CFR 862.1377, within the Clinical Chemistry review panel as a Class II device.