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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
510(k) Number K020870
Device Name VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
Applicant
bioMerieux, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2320
Applicant Contact Nancy Weaver
Correspondent
bioMerieux, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2320
Correspondent Contact Nancy Weaver
Regulation Number866.1645
Classification Product Code
LON  
Date Received12/28/2001
Decision Date 03/25/2002
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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