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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 K811281
Device Name GC CULTURE MEDIUM
Applicant
Biolog, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biolog, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2410
Classification Product Code
JTY  
Date Received05/08/1981
Decision Date 06/12/1981
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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