Clearance Summary
ISOTONIC DILUENT received FDA 510(k) clearance under submission number K790442, 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 1979-04-04.
- Submission: K790442
- Applicant / Sponsor: Royco Instruments
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8200
- Decision date: 1979-04-04
Classification & Regulation
This clearance is catalogued under FDA product code GIF and 21 CFR 864.8200, within the Hematology review panel as a Class I device.