Clearance Summary
ISOTONIC DILUENT AF received FDA 510(k) clearance under submission number K761182, sponsored by Central Labs. Assoc. MD Pathologists. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1976-12-09.
- Submission: K761182
- Applicant / Sponsor: Central Labs. Assoc. MD Pathologists
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8540
- Decision date: 1976-12-09
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.