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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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