Device Classification Name |
hexokinase, glucose
|
510(k) Number |
K170316 |
Device Name |
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM |
Applicant |
Abbott Laboratories |
Dept. 09AA, Bldg CP1-3, 100 Abbott Park Road |
Abbott Park,
IL
60064
|
|
Applicant Contact |
Noah Lermer |
Correspondent |
Abbott Laboratories |
Dept. 09AA, Bldg CP1-3, 100 Abbott Park Road |
Abbott Park,
IL
60064
|
|
Correspondent Contact |
Noah Lermer |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/01/2017 |
Decision Date | 10/19/2017 |
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
|
|
|