Clearance Summary
SICKLE CELL TEST KIT received FDA 510(k) clearance under submission number K932872, sponsored by Histo-Med, 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 1993-08-16.
- Submission: K932872
- Applicant / Sponsor: Histo-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7825
- Decision date: 1993-08-16
Classification & Regulation
This clearance is catalogued under FDA product code JBB and 21 CFR 864.7825, within the Hematology review panel as a Class II device.