Clearance Summary
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER received FDA 510(k) clearance under submission number K970227, sponsored by Dpc Cirrus. 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 1997-04-08.
- Submission: K970227
- Applicant / Sponsor: Dpc Cirrus
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 1997-04-08
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.