Clearance Summary
HEMOCUE GLUCOLIN received FDA 510(k) clearance under submission number K963909, sponsored by Direct Solutions. 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 1996-11-08.
- Submission: K963909
- Applicant / Sponsor: Direct Solutions
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1996-11-08
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.