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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