Clearance Summary
DIASCREEN REAGENT STRIPS received FDA 510(k) clearance under submission number K971976, sponsored by Dia-Screen Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1997-06-17.
- Submission: K971976
- Applicant / Sponsor: Dia-Screen Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 1997-06-17
Classification & Regulation
This clearance is catalogued under FDA product code LJX and 21 CFR 864.7675, within the Hematology review panel as a Class I device.