Clearance Summary
ACCESS HYBRITECH FREE PSA QC, MODEL 37219 received FDA 510(k) clearance under submission number K993210, sponsored by Beckman Coulter, Inc.. 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 2000-01-05.
- Submission: K993210
- Applicant / Sponsor: Beckman Coulter, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2000-01-05
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.