Clearance Summary
HEMACOUNT WRIGHTS STAIN PACK II #55952 received FDA 510(k) clearance under submission number K821457, sponsored by Accra Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1982-06-01.
- Submission: K821457
- Applicant / Sponsor: Accra Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1982-06-01
Classification & Regulation
This clearance is catalogued under FDA product code IAF and 21 CFR 864.1850, within the Hematology review panel as a Class I device.