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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, Enterobacteriaceae
510(k) Number K883558
Device Name VITEK GRAM-NEGATIVE IDENTIFICATION CARD
Applicant
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042 -2395
Applicant Contact L METCALF
Correspondent
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042 -2395
Correspondent Contact L METCALF
Regulation Number866.2660
Classification Product Code
JSS  
Date Received08/19/1988
Decision Date 09/16/1988
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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