Device Classification Name |
assay, glycosylated hemoglobin |
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---|---|---|---|---|
510(k) Number | K111128 | |||
Device Name | LABONACHECK A1C | |||
Applicant |
|
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Applicant Contact | raymond chung | |||
Correspondent |
|
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Correspodent Contact | raymond chung | |||
Regulation Number | 864.7470 | |||
Classification Product Code |
|
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Date Received | 04/21/2011 | |||
Decision Date | 09/13/2012 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Hematology |
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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 |