Device Classification Name |
enzymatic methods, galactose
|
510(k) Number |
K190335 |
Device Name |
GSP Neonatal Total Galactose kit |
Applicant |
PerkinElmer Inc. |
940 Winter Street |
Waltham,
MA
02451
|
|
Applicant Contact |
Brian Ciccariello |
Correspondent |
PerkinElmer Inc. |
940 Winter Street |
Waltham,
MA
02451
|
|
Correspondent Contact |
Brian Ciccariello |
Regulation Number | 862.1310
|
Classification Product Code |
|
Date Received | 02/14/2019 |
Decision Date | 11/06/2019 |
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
|
|
|