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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, Enriched
510(k) Number K871092
Device Name HORSE BLOOD AGAR, ENRICHED
Applicant
bioMerieux, Inc.
421 Irmen Dr.
Addison,  IL  60101
Applicant Contact MICKI A MAXWELL
Correspondent
bioMerieux, Inc.
421 Irmen Dr.
Addison,  IL  60101
Correspondent Contact MICKI A MAXWELL
Regulation Number866.2330
Classification Product Code
KZI  
Date Received03/18/1987
Decision Date 04/03/1987
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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