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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, General Nutrient Broth
510(k) Number K790687
Device Name BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2
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 Number866.2350
Classification Product Code
JSC  
Date Received04/10/1979
Decision Date 05/03/1979
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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