Clearance Summary
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 received FDA 510(k) clearance under submission number K012878, sponsored by Thermo Dma, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2001-10-16.
- Submission: K012878
- Applicant / Sponsor: Thermo Dma, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2001-10-16
Classification & Regulation
This clearance is catalogued under FDA product code JIS and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.