Clearance Summary
V-MARC 88A COMPUTER received FDA 510(k) clearance under submission number K871853, sponsored by V.Marc, A Div. of Pictorial, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1987-07-16.
- Submission: K871853
- Applicant / Sponsor: V.Marc, A Div. of Pictorial, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2100
- Decision date: 1987-07-16
Classification & Regulation
This clearance is catalogued under FDA product code JQP and 21 CFR 862.2100, within the Clinical Chemistry review panel as a Class I device.