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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 K823880
Device Name BACTIGEN-N. MENINGITIDIS
Applicant
Armkel, LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Armkel, LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3390
Classification Product Code
GTJ  
Date Received12/27/1982
Decision Date 03/09/1983
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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