Clearance Summary
RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA received FDA 510(k) clearance under submission number K071867, sponsored by Paragondx, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2008-04-28.
- Submission: K071867
- Applicant / Sponsor: Paragondx, LLC
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7750
- Decision date: 2008-04-28
Classification & Regulation
This clearance is catalogued under FDA product code ODV and 21 CFR 864.7750, within the Hematology review panel as a Class II device.