Clearance Summary
ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM received FDA 510(k) clearance under submission number K974322, sponsored by Europa Scientific, Ltd.. 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 1997-12-16.
- Submission: K974322
- Applicant / Sponsor: Europa Scientific, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2860
- Decision date: 1997-12-16
Classification & Regulation
This clearance is catalogued under FDA product code DOP and 21 CFR 862.2860, within the Clinical Chemistry review panel as a Class I device.