Clearance Summary
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II received FDA 510(k) clearance under submission number K883836, sponsored by Coulter Immunology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1988-11-30.
- Submission: K883836
- Applicant / Sponsor: Coulter Immunology
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8540
- Decision date: 1988-11-30
Classification & Regulation
This clearance is catalogued under FDA product code GGK and 21 CFR 864.8540, within the Hematology review panel as a Class I device.