Device Classification Name |
system, test, blood glucose, over the counter |
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---|---|---|---|---|
510(k) Number | K122142 | |||
Device Name | GLOOKO LOGBOOK CHARTS | |||
Applicant |
|
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Applicant Contact | shilpa mydur | |||
Correspondent |
|
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Correspodent Contact | shilpa mydur | |||
Regulation Number | 862.1345 | |||
Classification Product Code |
|
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Subsequent Product Code |
|
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Date Received | 07/19/2012 | |||
Decision Date | 12/21/2012 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Clinical Chemistry |
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510k Review Panel |
Clinical Chemistry |
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summary |
summary |
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FDA Review | Decision Summary | |||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |