Clearance Summary
MODEL 5790 GAS CHROMATOGRAPH received FDA 510(k) clearance under submission number K820071, 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 1982-01-28.
- Submission: K820071
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2250
- Decision date: 1982-01-28
Classification & Regulation
This clearance is catalogued under FDA product code KZQ and 21 CFR 862.2250, within the Clinical Chemistry review panel as a Class I device.