Clearance Summary
AMES/GILFORD OPTIMATE CLIN. CHEM & THER received FDA 510(k) clearance under submission number K821583, sponsored by Gilford Instrument Laboratories, 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 1982-06-24.
- Submission: K821583
- Applicant / Sponsor: Gilford Instrument Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2170
- Decision date: 1982-06-24
Classification & Regulation
This clearance is catalogued under FDA product code JJF and 21 CFR 862.2170, within the Clinical Chemistry review panel as a Class I device.