Clearance Summary
ROYCO MODEL 371 SUPER DILUTOR received FDA 510(k) clearance under submission number K791644, sponsored by Royco Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1979-09-19.
- Submission: K791644
- Applicant / Sponsor: Royco Instruments
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.5240
- Decision date: 1979-09-19
Classification & Regulation
This clearance is catalogued under FDA product code GKH and 21 CFR 864.5240, within the Hematology review panel as a Class I device.