Clearance Summary
COUITER/CMS ISOTONIC BLOOD BANK SALINE received FDA 510(k) clearance under submission number K792101, sponsored by Coulter Electronics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1979-11-20.
- Submission: K792101
- Applicant / Sponsor: Coulter Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1979-11-20
Classification & Regulation
This clearance is catalogued under FDA product code JCE and 21 CFR 864.4010, within the Pathology review panel as a Class I device.