Device Classification Name |
photometric method, magnesium
|
510(k) Number |
K173294 |
Device Name |
Magnesium |
Applicant |
Abbott Laboratories |
1921 Hurd Drive |
Irving,
TX
75038
|
|
Applicant Contact |
Kimberly Senseman |
Correspondent |
Abbott Laboratories |
1921 Hurd Drive |
Irving,
TX
75038
|
|
Correspondent Contact |
Kimberly Senseman |
Regulation Number | 862.1495
|
Classification Product Code |
|
Date Received | 10/16/2017 |
Decision Date | 05/18/2018 |
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
|
|
|