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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-selective and differential
510(k) Number K851602
Device Name UREA AGAR
Applicant
PREFERRED MICRO-MEDIA
5223 telegraph rd.
toledo,  OH  43612
Applicant Contact robert scott
Correspondent
PREFERRED MICRO-MEDIA
5223 telegraph rd.
toledo,  OH  43612
Correspondent Contact robert scott
Regulation Number866.2320
Classification Product Code
JSH  
Date Received04/16/1985
Decision Date 05/08/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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