Clearance Summary
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls received FDA 510(k) clearance under submission number K140654, sponsored by Abbott Laboratories. 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 2015-05-22.
- Submission: K140654
- Applicant / Sponsor: Abbott Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1373
- Decision date: 2015-05-22
Classification & Regulation
This clearance is catalogued under FDA product code PDJ and 21 CFR 862.1373, within the Clinical Chemistry review panel as a Class II device.