Clearance Summary
DIGENE DCR-1 LUMINOMETER received FDA 510(k) clearance under submission number K940486, sponsored by Digene Diagnostics, 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 1995-04-18.
- Submission: K940486
- Applicant / Sponsor: Digene Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1995-04-18
Classification & Regulation
This clearance is catalogued under FDA product code JJQ and 21 CFR 862.2300, within the Clinical Chemistry review panel as a Class I device.