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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Glucose Nonfermenter
510(k) Number K922768
Device Name RAPID NFT, MODIFICATION
Applicant
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2395
Applicant Contact DAVID K BROADWAY
Correspondent
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2395
Correspondent Contact DAVID K BROADWAY
Regulation Number866.2660
Classification Product Code
JSW  
Date Received06/08/1992
Decision Date 10/14/1992
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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