Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K113830 |
FOIA Releasable 510(k) |
K113830
|
Device Name |
VANTERA CLINICAL ANALYZER |
Applicant |
LIPOSCIENCE |
2500 SUMMER BLVD. |
RALEIGH,
NC
27616
|
|
Applicant Contact |
SUZETTE WARNER |
Correspondent |
LIPOSCIENCE |
2500 SUMMER BLVD. |
RALEIGH,
NC
27616
|
|
Correspondent Contact |
SUZETTE WARNER |
Regulation Number | 862.1705
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/27/2011 |
Decision Date | 08/30/2012 |
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
|
|
|