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Document Number | K100398 |
Test Name | DAVAK Scientific, STANDARD GlucoNavii Blood Glucose Monitoring System |
Manufacturer Name | STANDARD DIAGNOSTICS, INC. |
Consumer Information Phone Number | 1(855)486-2888 |
Test Type | Glucose monitoring devices (FDA cleared/home use) |
Effective Date | 08/09/2024 |
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Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K100398 |
Device Name |
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
STANDARD DIAGNOSTICS, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021 -1734
|
|
Applicant Contact |
SUSAN GOLDSTEIN-FALK |
Correspondent |
STANDARD DIAGNOSTICS, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021 -1734
|
|
Correspondent Contact |
SUSAN GOLDSTEIN-FALK |
Regulation Number | 862.1345
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Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/16/2010 |
Decision Date | 06/09/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
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|
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