Clearance Summary
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 received FDA 510(k) clearance under submission number K012525, sponsored by Thermo Dma, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2001-10-04.
- Submission: K012525
- Applicant / Sponsor: Thermo Dma, Inc.
- Clearance pathway: Abbreviated
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2001-10-04
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.