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CLIA record K080107 and corresponding
510(K) Premarket Notification information

Test System NameVitek 2 Antimicrobial Susceptibility Test (Ast)  {Gram Negative Piperacillin/tazobactam; Automated} 
Document Number K080107
Analyte NameAntimicrobial
Analyte SpecialtyBacteriology
ComplexityHIGH
Effective Date03/12/2008

510(k) Premarket Notification Database

Device Classification Name system, test, automated, antimicrobial susceptibility, short incubation
510(k) NumberK080107
Device NameVITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood,  MO  63042
Contactnancy weaver
Regulation Number866.1645
Classification Product Code
LON
Date Received01/15/2008
Decision Date 02/28/2008
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Statement/Summary/Purged Status Summary only
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

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