Clearance Summary
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA received FDA 510(k) clearance under submission number K973628, sponsored by Vital Scientific N.V.. 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 1998-03-13.
- Submission: K973628
- Applicant / Sponsor: Vital Scientific N.V.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2170
- Decision date: 1998-03-13
Classification & Regulation
This clearance is catalogued under FDA product code JJF and 21 CFR 862.2170, within the Clinical Chemistry review panel as a Class I device.