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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, N. Meningitidis
510(k) Number K844762
Device Name MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
Applicant
Wellcome Diagnostics
3030 Cornwallis Rd.
Research Triangle Pk,  NC  27709
Applicant Contact MAX D MOODY
Correspondent
Wellcome Diagnostics
3030 Cornwallis Rd.
Research Triangle Pk,  NC  27709
Correspondent Contact MAX D MOODY
Regulation Number866.3390
Classification Product Code
GTJ  
Date Received12/07/1984
Decision Date 06/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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