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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
510(k) Number K863868
Device Name IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
Applicant
Cooper Biomedical, Inc.
One Technology Court
Malvern,  PA  19355
Applicant Contact BREWSTER, PHD
Correspondent
Cooper Biomedical, Inc.
One Technology Court
Malvern,  PA  19355
Correspondent Contact BREWSTER, PHD
Regulation Number866.5080
Classification Product Code
DFF  
Date Received10/03/1986
Decision Date 02/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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