Clearance Summary
COLLAGENREAGENT HORM received FDA 510(k) clearance under submission number K781693, sponsored by Hormon-Chemie Munchem Gmch. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1978-12-07.
- Submission: K781693
- Applicant / Sponsor: Hormon-Chemie Munchem Gmch
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5700
- Decision date: 1978-12-07
Classification & Regulation
This clearance is catalogued under FDA product code JOZ and 21 CFR 864.5700, within the Hematology review panel as a Class II device.