Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K160402 |
Device Name |
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) |
Applicant |
Instrumentation Laboratory Co. |
180 Hartwell Road |
Bedford,
MA
01730
|
|
Applicant Contact |
Carol Murble |
Correspondent |
Instrumentation Laboratory Co. |
180 Hartwell Road |
Bedford,
MA
01730
|
|
Correspondent Contact |
Carol Marble |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/12/2016 |
Decision Date | 12/14/2016 |
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
|
|
|