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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 K141506
Device Name MCC Para-Fix CARY BLAIR MEDIUM
Applicant
Medical Chemical Corporation
19430 Van Ness Ave.
Torrance,  CA  90501
Applicant Contact KRIS J KONTIS
Correspondent
Medical Chemical Corporation
19430 Van Ness Ave.
Torrance,  CA  90501
Correspondent Contact KRIS J KONTIS
Regulation Number866.2390
Classification Product Code
JSM  
Subsequent Product Code
LIO  
Date Received06/06/2014
Decision Date 02/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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