Clearance Summary
GAMBRO DQM 200 received FDA 510(k) clearance under submission number K990039, sponsored by Gambro Healthcare. 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 2000-01-27.
- Submission: K990039
- Applicant / Sponsor: Gambro Healthcare
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 2000-01-27
Classification & Regulation
This clearance is catalogued under FDA product code LFP and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.