Clearance Summary
MICRO-MAT SYSTEM received FDA 510(k) clearance under submission number K854121, sponsored by Prevo Micro-Mat System. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-10-31.
- Submission: K854121
- Applicant / Sponsor: Prevo Micro-Mat System
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.5850
- Decision date: 1985-10-31
Classification & Regulation
This clearance is catalogued under FDA product code GKJ and 21 CFR 864.5850, within the Hematology review panel as a Class I device.