Clearance Summary
ACRIDINE ORANGE STAIN received FDA 510(k) clearance under submission number K803304, sponsored by Remel Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1981-02-12.
- Submission: K803304
- Applicant / Sponsor: Remel Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1981-02-12
Classification & Regulation
This clearance is catalogued under FDA product code IDC and 21 CFR 864.1850, within the Hematology review panel as a Class I device.