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 |