RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
FDA 510(k) clearance K071867 · decided 2008-04-28
Clearance details
- K-number
- K071867
- Device name
- RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
- Applicant
- Paragondx, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-07-06
- Decision date
- 2008-04-28
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- ODV
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.