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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gram positive identification panel
510(k) Number K925916
Device Name VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
Applicant
BIOMERIEUX VITEK, INC.
595 ANGLUM DR.
hazelwood,  MO  63042 -2395
Applicant Contact cheryl winters-heard
Correspondent
BIOMERIEUX VITEK, INC.
595 ANGLUM DR.
hazelwood,  MO  63042 -2395
Correspondent Contact cheryl winters-heard
Regulation Number866.2660
Classification Product Code
LQL  
Date Received11/23/1992
Decision Date 03/23/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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