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FDA 510(k) Applications Submitted by Karen Russell
FDA 510(k) Number
Submission Date
Device Name
Applicant
K060661
03/13/2006
MACTRODE 3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K161217
04/29/2016
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
bioMerieux, Inc.
K161437
05/24/2016
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
BIOMERIEUX, INC.
K151817
07/06/2015
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
BIOMERIEUX INC
K162076
07/27/2016
chromID MRSA
bioMerieux, Inc.
K163042
10/31/2016
chromID Strepto B agar
bioMerieux, Inc.
K073203
11/13/2007
CARESCAPE V100
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K072598
09/14/2007
IRSG I-MOVER FOR BEDS
INTERNATIONAL RETAIL SERVICES GROUP, LLC
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