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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, For Isolation Of Pathogenic Neisseria
510(k) Number K820847
Device Name ISOLATION OF PATHOGENIC NEISSERIA
Applicant
Blue Ridge Media Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Blue Ridge Media Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2410
Classification Product Code
JTY  
Date Received03/26/1982
Decision Date 04/16/1982
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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