FDA 510(k), K011566, QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

FDA 510(k), K011566, QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

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510(K) Number: K011566
Device Name: QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
Manufacturer:
Device Classification Name: Autoantibodies, Endomysial(Tissue Transglutaminase)
Regulation Number: 866.5660
Classification Product Code: MVM
Date Received: 05/21/2001
Decision Date: 07/09/2001
Regulation Medical Specialty: Immunology
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