Clearance Summary
PHYSIOLOGIC SALINE (0.85%) received FDA 510(k) clearance under submission number K761174, sponsored by Bio/Data Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1977-01-10.
- Submission: K761174
- Applicant / Sponsor: Bio/Data Corp.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1977-01-10
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.