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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, Multiple Biochemical Test
510(k) Number K812911
Device Name BCYE 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 Number866.2320
Classification Product Code
JSE  
Date Received10/19/1981
Decision Date 11/06/1981
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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