The following data is part of a premarket notification filed by Paragondx, Llc with the FDA for Rapid Genotyping Assay -cyp2c9 & Vkorc1, Model Catalog No. 006+0203 Gactga.
| Device ID | K071867 |
| 510k Number | K071867 |
| Device Name: | RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA |
| Classification | Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System |
| Applicant | PARAGONDX, LLC 133 SOUTHCENTER COURT SUITE 200 Morrisville, NC 27560 |
| Contact | Deborah N Kloos |
| Correspondent | Deborah N Kloos PARAGONDX, LLC 133 SOUTHCENTER COURT SUITE 200 Morrisville, NC 27560 |
| Product Code | ODV |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-06 |
| Decision Date | 2008-04-28 |