FDA 510(k) Application Details - K891093

Device Classification Name Beta-Globulin, Antigen, Antiserum, Control

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510(K) Number K891093
Device Name Beta-Globulin, Antigen, Antiserum, Control
Applicant E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON, DE US
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Contact RICHARD M VAUGHT
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Regulation Number 866.5160

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Classification Product Code DCJ
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Date Received 03/02/1989
Decision Date 04/26/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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