Clearance Summary
ERYTHROCYTE TEST received FDA 510(k) clearance under submission number K832771, sponsored by Bio-Analytics 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 1983-10-28.
- Submission: K832771
- Applicant / Sponsor: Bio-Analytics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7100
- Decision date: 1983-10-28
Classification & Regulation
This clearance is catalogued under FDA product code LKZ and 21 CFR 864.7100, within the Hematology review panel as a Class II device.