Clearance Summary
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL received FDA 510(k) clearance under submission number K133816, sponsored by Siemens Healthcare Diagnostics, 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 2014-06-24.
- Submission: K133816
- Applicant / Sponsor: Siemens Healthcare Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2014-06-24
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.