| Device Classification Name |
alcohol dehydrogenase, specific reagent for ethanol enzyme method |
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|---|---|---|---|---|
| 510(k) Number | K111206 | |||
| Device Name | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | |||
| Applicant |
|
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| Applicant Contact | james li | |||
| Correspondent |
|
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| Correspodent Contact | james li | |||
| Regulation Number | 862.3040 | |||
| Classification Product Code |
|
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| Date Received | 04/29/2011 | |||
| Decision Date | 10/04/2011 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Toxicology |
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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 |