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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Fastidious Organisms
510(k) Number K854732
Device Name API 50 CHB (CULTURE MEDIA)
Applicant
Dms Products, Inc.
Dart'S Mill Professional Vill.
Rt. 523, Box 95
Flemington,  NJ  08822
Correspondent
Dms Products, Inc.
Dart'S Mill Professional Vill.
Rt. 523, Box 95
Flemington,  NJ  08822
Regulation Number866.2660
Classification Product Code
JST  
Date Received11/25/1985
Decision Date 03/04/1986
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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