Clearance Summary
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) received FDA 510(k) clearance under submission number K973335, sponsored by Zenyx 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 1998-04-30.
- Submission: K973335
- Applicant / Sponsor: Zenyx Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2750
- Decision date: 1998-04-30
Classification & Regulation
This clearance is catalogued under FDA product code JQW and 21 CFR 862.2750, within the Clinical Chemistry review panel as a Class I device.