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Document Number | K133260 |
Test Name | Tianjin Empecs Medisign MM3000 Multi Blood Glucose Monitoring System |
Manufacturer Name | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
Consumer Information Phone Number | (888)885-6677 |
Test Type | Glucose monitoring devices (FDA cleared/home use) |
Effective Date | 07/01/2014 |
| |
Device Classification Name |
System, Test, Blood Glucose, Over The Counter
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510(k) Number |
K133260 |
Device Name |
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
2651 E CHAPMAN AVE STE 110 |
FULLERTON,
CA
92831
|
|
Applicant Contact |
Priscilla Chung |
Correspondent |
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
2651 E CHAPMAN AVE STE 110 |
FULLERTON,
CA
92831
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 862.1345
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Classification Product Code |
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Subsequent Product Codes |
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Date Received | 10/23/2013 |
Decision Date | 06/27/2014 |
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
|
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