FDA 510(k) Applications Submitted by RUSSEL K ENNS, PH.D.

FDA 510(k) Number Submission Date Device Name Applicant
K110203 01/24/2011 XPERT C. DIFFICLE/EPI ASSAY CEPHEID
K010288 01/31/2001 ANEUVYSION MULITICOLOR DNA PROBE KIT VYSIS
K070462 02/16/2007 XPERT MRSA CEPHEID
K060540 03/01/2006 XPERT, GENEXPERT DX SYSTEM CEPHEID
K100822 03/23/2010 XPERT MRSA/SA NASAL ASSAY CEPHEID
K011031 04/05/2001 VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT VYSIS
K091109 04/16/2009 XPERT C. DIFFICILE CEPHEID
K121710 06/11/2012 XPERT CT/NG CEPHEID
K962873 07/23/1996 CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE VYSIS
K082118 07/28/2008 XPERT HEMOSIL FACTOR II & FACTOR V ASSAY CEPHEID
K082140 07/30/2008 XPERT MRSA/SA BLOOD CULTURE ASSAY CEPHEID
K092953 09/24/2009 XPERT VANA ASSAY CEPHEID
K062948 09/28/2006 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B CEPHEID
K123191 10/11/2012 XPERT FLU CEPHEID
K013785 11/14/2001 UROVYSION BLADDER CANCER RECURRENCE KIT VYSIS
DEN070004 03/12/2007 XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 CEPHEID
K101879 07/06/2010 XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 CEPHEID
K953591 08/01/1995 CEP 8 SPECTRUMORANGE DNA PROBE KIT VYSIS


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