510(k) K071867
- Device
- RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
- Applicant
- PARAGONDX, LLC
- 510(k) number
- K071867
- Product code
- ODV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-28
- Date received
- 2007-07-06
- Regulation
- 864.7750
- Classification name
- Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System
- Medical specialty
- Hematology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBORAH N KLOOS
- Address
- 133 Southcenter Ct. Suite 200 Morrisville NC US 27560 27560
FDA Registration Numbers#
- 3005406097
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
Decision Summary