Device Classification Name |
system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry
|
510(k) Number |
K193103 |
Device Name |
NeoBase 2 Non-derivatized MSMS Kit |
Applicant |
PerkinElmer Inc. |
940 Winter Street |
Waltham,
MA
02451
|
|
Applicant Contact |
Eva Nalian |
Correspondent |
PerkinElmer Inc. |
940 Winter Street |
Waltham,
MA
02451
|
|
Correspondent Contact |
Eva Nalian |
Regulation Number | 862.1055
|
Classification Product Code |
|
Date Received | 11/08/2019 |
Decision Date | 02/07/2020 |
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
|
|
|