Device Classification Name |
hexokinase, glucose
|
510(k) Number |
K113131 |
Device Name |
LIASYS 450 |
Applicant |
AMS |
17/A VIA E. BARSANTI |
GUIDONIA, ROME,
IT
I-00012
|
|
Applicant Contact |
STEFANO CORRADI |
Correspondent |
AMS |
17/A VIA E. BARSANTI |
GUIDONIA, ROME,
IT
I-00012
|
|
Correspondent Contact |
STEFANO CORRADI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/24/2011 |
Decision Date | 03/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|