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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 K770287
Device Name MARTIN-LEWIS AGAR MEDIUM
Applicant
Gibco Laboratories Life Technologies, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gibco Laboratories Life Technologies, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2410
Classification Product Code
JTY  
Date Received02/14/1977
Decision Date 02/18/1977
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
Recalls CDRH Recalls
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