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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 K854454
Device Name TRYPTIC SOY BLOOD AGAR
Applicant
R. Kent Richards, Inc.
45 W. Center
Pl. Grove,  UT  84062
Applicant Contact KENT RICHARDS
Correspondent
R. Kent Richards, Inc.
45 W. Center
Pl. Grove,  UT  84062
Correspondent Contact KENT RICHARDS
Regulation Number866.2330
Classification Product Code
KZI  
Date Received11/05/1985
Decision Date 11/18/1985
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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