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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
Recalls CDRH Recalls
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