Clearance Summary
ISOTONIC DILUENT received FDA 510(k) clearance under submission number K781008, sponsored by Mallinckrodt Critical Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1978-06-28.
- Submission: K781008
- Applicant / Sponsor: Mallinckrodt Critical Care
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8200
- Decision date: 1978-06-28
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.