Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K133067 |
Device Name |
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
KIRA GORDON |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
KIRA GORDON |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 09/27/2013 |
Decision Date | 11/22/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|