Clearance Summary
DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 received FDA 510(k) clearance under submission number K860784, sponsored by Tissue Culture Innovations. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1986-03-12.
- Submission: K860784
- Applicant / Sponsor: Tissue Culture Innovations
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2875
- Decision date: 1986-03-12
Classification & Regulation
This clearance is catalogued under FDA product code KIP and 21 CFR 864.2875, within the Hematology review panel as a Class I device.