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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 K854852
Device Name WELLCOGEN BACTERIAL ANTIGEN KIT
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 Received12/05/1985
Decision Date 02/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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