Clearance Summary
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 received FDA 510(k) clearance under submission number K000527, sponsored by Sigma Diagnostics, 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 2000-04-07.
- Submission: K000527
- Applicant / Sponsor: Sigma Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8950
- Decision date: 2000-04-07
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.