NMR LIPOPROFILE (R) TEST AND NMR PROFILER


Device Classification Name

ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl

510(k) Number K111516
Device Name NMR LIPOPROFILE (R) TEST AND NMR PROFILER
Applicant
LIPOSCIENCE, INC
2500 sumner blvd
raleigh, 
NC 
27616

Applicant Contact suzette m warner
Correspondent
LIPOSCIENCE, INC
2500 sumner blvd
raleigh, 
NC 
27616

Correspodent Contact suzette m warner
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Codes
CDT   MRR  
Date Received 06/01/2011
Decision Date 09/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No