Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K141656 |
Device Name |
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
Philosys Inc. |
304 PARK AVENUE SOUTH |
SUITE 218 |
NEW YORK,
NY
10010
|
|
Applicant Contact |
LINDA CHAN |
Correspondent |
PHILOSYS, INC. |
304 PARK AVENUE SOUTH |
SUITE 218 |
NEW YORK,
NY
10010
|
|
Correspondent Contact |
LINDA CHAN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/20/2014 |
Decision Date | 10/02/2015 |
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
|
|
|