Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system
510(k) Number K071867
Device Name RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
Applicant
PARAGONDX, LLC
133 SOUTHCENTER COURT
SUITE 200
MORRISVILLE,  NC  27560
Applicant Contact DEBORAH N KLOOS
Correspondent
PARAGONDX, LLC
133 SOUTHCENTER COURT
SUITE 200
MORRISVILLE,  NC  27560
Correspondent Contact DEBORAH N KLOOS
Regulation Number864.7750
Classification Product Code
ODV  
Subsequent Product Code
ODW  
Date Received07/06/2007
Decision Date 04/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-