Clearance Summary
HEMASTIX REAGENT STRIPS received FDA 510(k) clearance under submission number K905396, sponsored by Heraeus Kulzer, 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 1991-02-11.
- Submission: K905396
- Applicant / Sponsor: Heraeus Kulzer, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 1991-02-11
Classification & Regulation
This clearance is catalogued under FDA product code JIO and 21 CFR 864.6550, within the Hematology review panel as a Class II device.