Clearance Summary
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER received FDA 510(k) clearance under submission number K022603, sponsored by Diagnostic Products Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2002-08-21.
- Submission: K022603
- Applicant / Sponsor: Diagnostic Products Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1545
- Decision date: 2002-08-21
Classification & Regulation
This clearance is catalogued under FDA product code CEW and 21 CFR 862.1545, within the Clinical Chemistry review panel as a Class II device.