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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 K950196
Device Name CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
Applicant
Bioclinical Systems, Inc.
9040 Junction Dr.
Annapolis Junction,  MD  20701
Applicant Contact KATHRYN B POWERS
Correspondent
Bioclinical Systems, Inc.
9040 Junction Dr.
Annapolis Junction,  MD  20701
Correspondent Contact KATHRYN B POWERS
Regulation Number866.2410
Classification Product Code
JTY  
Date Received01/18/1995
Decision Date 06/30/1995
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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