Clearance Summary
V-MARC 88A COMPUTER received FDA 510(k) clearance under submission number K862089, sponsored by V.Marc, A Div. of Pictorial, 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 1986-07-10.
- Submission: K862089
- Applicant / Sponsor: V.Marc, A Div. of Pictorial, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5300
- Decision date: 1986-07-10
Classification & Regulation
This clearance is catalogued under FDA product code KQH and 21 CFR 864.5300, within the Hematology review panel as a Class II device.