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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, Non-Propagating Transport
510(k) Number K871065
Device Name CHLAMYDIA & VIRAL TRANSPORT MEDIUM
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 Number866.2390
Classification Product Code
JSM  
Date Received03/18/1987
Decision Date 04/14/1987
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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