Clearance Summary
REPORTING INTEGRATOR 3392A received FDA 510(k) clearance under submission number K833113, sponsored by Hewlett-Packard Co.. 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 1983-11-21.
- Submission: K833113
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1983-11-21
Classification & Regulation
This clearance is catalogued under FDA product code LDM and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.