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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Antigen, Antiserum, Control
510(k) Number K851284
Device Name RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
Applicant
Cooper Biomedical, Inc.
One Technology Ct.
Malvern,  PA  19355
Applicant Contact AMIRAM DANIEL
Correspondent
Cooper Biomedical, Inc.
One Technology Ct.
Malvern,  PA  19355
Correspondent Contact AMIRAM DANIEL
Regulation Number866.5510
Classification Product Code
CZP  
Date Received04/01/1985
Decision Date 06/11/1985
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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