| Device Classification Name |
enzyme immunoassay, non-radiolabeled, total thyroxine |
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|---|---|---|---|---|
| 510(k) Number | K131515 | |||
| Device Name | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | |||
| Applicant |
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| Applicant Contact | hyman katz, ph.d. | |||
| Correspondent |
|
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| Correspodent Contact | hyman katz, ph.d. | |||
| Regulation Number | 862.1700 | |||
| Classification Product Code |
|
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| Subsequent Product Codes |
|
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| Date Received | 05/28/2013 | |||
| Decision Date | 08/14/2013 | |||
| 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 |