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Document Number | K103542 |
Test Name | LifeScan OneTouch UltraMini Blood Glucose Meter {Shasta Technologies LLC GenStrip Test Strips} |
Manufacturer Name | SHASTA TECHNOLOGIES, LLC |
Consumer Information Phone Number | 1(866)708-0154 |
Test Type | Glucose monitoring devices (FDA cleared/home use) |
Effective Date | 01/11/2013 |
| |
Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K103542 |
Device Name |
GENSTRIP TEST STRIP MODEL 100-201 |
Applicant |
SHASTA TECHNOLOGIES, LLC |
611 W 5TH ST. |
3RD FLOOR |
AUSTIN,
TX
78701
|
|
Applicant Contact |
CAROLINE TONTINI |
Correspondent |
SHASTA TECHNOLOGIES, LLC |
611 W 5TH ST. |
3RD FLOOR |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
CAROLINE TONTINI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/02/2010 |
Decision Date | 11/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|
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