definition
| Device Classification Name |
autoantibodies, endomysial(tissue transglutaminase) |
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|---|---|---|---|---|
| 510(k) Number | K002107 | |||
| Device Name | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. | |||
| Original Applicant |
|
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| Original Contact | gary lehnus,ph.d | |||
| Regulation Number | 866.5660 | |||
| Classification Product Code |
|
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| Date Received | 07/12/2000 | |||
| Decision Date | 08/04/2000 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Immunology |
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| 510k Review Panel |
Immunology |
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| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |