• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K113830
Model 003-00095 ADH
Device Name VANTERA CLINICAL ANALYZER
Original Applicant
LIPOSCIENCE
2500 summer blvd.
raleigh,  NC  27616
Original Contact suzette warner
Regulation Number862.1705
Classification Product Code
CDT  
Subsequent Product Codes
LBS   MRR   NSU  
Date Received12/27/2011
Decision Date 08/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-