Clearance Summary
FIBRO-TEC TEST KIT received FDA 510(k) clearance under submission number K791358, sponsored by Calbiochem-Behring Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1979-09-04.
- Submission: K791358
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 1979-09-04
Classification & Regulation
This clearance is catalogued under FDA product code GHH and 21 CFR 864.7320, within the Hematology review panel as a Class II device.