Clearance Summary
LYSING & HEMOGLOBIN S-REAGENT J & S received FDA 510(k) clearance under submission number K833444, sponsored by Jasins & Sayles Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1983-11-03.
- Submission: K833444
- Applicant / Sponsor: Jasins & Sayles Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8540
- Decision date: 1983-11-03
Classification & Regulation
This clearance is catalogued under FDA product code GGK and 21 CFR 864.8540, within the Hematology review panel as a Class I device.