Clearance Summary
DV TEST AND DVV CONFIRM received FDA 510(k) clearance under submission number K940490, sponsored by American Diagnostica, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1995-04-05.
- Submission: K940490
- Applicant / Sponsor: American Diagnostica, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8950
- Decision date: 1995-04-05
Classification & Regulation
This clearance is catalogued under FDA product code GIR and 21 CFR 864.8950, within the Hematology review panel as a Class I device.