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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram Negative Identification Panel
510(k) Number K911429
Device Name VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
Applicant
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042 -2395
Applicant Contact DAVID K BROADWAY
Correspondent
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042 -2395
Correspondent Contact DAVID K BROADWAY
Regulation Number866.2660
Classification Product Code
LQM  
Date Received03/26/1991
Decision Date 06/24/1991
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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