Clearance Summary
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS received FDA 510(k) clearance under submission number K992163, sponsored by Pdz-Europa , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1999-07-13.
- Submission: K992163
- Applicant / Sponsor: Pdz-Europa , Ltd.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2860
- Decision date: 1999-07-13
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.