Clearance Summary
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER received FDA 510(k) clearance under submission number K032608, sponsored by Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB. 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 2003-10-21.
- Submission: K032608
- Applicant / Sponsor: Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2003-10-21
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.