Clearance Summary
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY received FDA 510(k) clearance under submission number K020217, sponsored by Bayer Diagnostics Corp.. 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 2002-03-15.
- Submission: K020217
- Applicant / Sponsor: Bayer Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2002-03-15
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.