Device Classification Name |
system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry
|
510(k) Number |
K093916 |
Device Name |
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U |
Applicant |
PERKINELMER, INC. |
8275 CARLOWAY ROAD |
INDIANAPOLIS,
IN
46236
|
|
Applicant Contact |
KAY TAYLOR |
Correspondent |
PERKINELMER, INC. |
8275 CARLOWAY ROAD |
INDIANAPOLIS,
IN
46236
|
|
Correspondent Contact |
KAY TAYLOR |
Regulation Number | 862.1055
|
Classification Product Code |
|
Date Received | 12/22/2009 |
Decision Date | 08/23/2010 |
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
|
|
|