Clearance Summary
COUNT-10 STAIN received FDA 510(k) clearance under submission number K823363, sponsored by V-Tech, 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 1982-12-15.
- Submission: K823363
- Applicant / Sponsor: V-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1982-12-15
Classification & Regulation
This clearance is catalogued under FDA product code LEE and 21 CFR 864.1850, within the Hematology review panel as a Class I device.