| 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 |
|
|||
| 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 |
|||
| FDA Review | Decision Summary | |||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |