FDA 510(k) Applications Submitted by BIONOSTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K980178 01/20/1998 OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY BIONOSTICS, INC.
K972868 08/04/1997 TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL BIONOSTICS, INC.
K955630 12/11/1995 RNA MEDICAL HEMAT CONTROL BIONOSTICS, INC.
K000318 02/01/2000 BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM BIONOSTICS, INC.
K050961 04/18/2005 RNA1C CONTROL FOR NYCOCARD HBA1C BIONOSTICS, INC.
K021624 05/16/2002 RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 BIONOSTICS, INC.
K021697 05/22/2002 GLUCOSE CONTROL SOLUTION FOR BD LATITUDE BIONOSTICS, INC.
K081478 05/27/2008 RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS BIONOSTICS, INC.
K032453 08/11/2003 ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL BIONOSTICS, INC.
K002540 08/16/2000 BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS BIONOSTICS, INC.
K082395 08/19/2008 GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 BIONOSTICS, INC.
K022769 08/21/2002 LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION BIONOSTICS, INC.
K032819 09/10/2003 GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM BIONOSTICS, INC.
K053327 12/01/2005 OXICOM CONTROL BIONOSTICS, INC.
K050100 01/18/2005 RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER BIONOSTICS, INC.
K021924 06/11/2002 MEDICA EASYQC HEMATOCRIT CONTROL BIONOSTICS, INC.
K021930 06/12/2002 MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL BIONOSTICS, INC.
K012430 07/31/2001 MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 BIONOSTICS, INC.
K012431 07/31/2001 COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 BIONOSTICS, INC.
K013147 09/20/2001 GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE BIONOSTICS, INC.
K091914 06/30/2009 OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION BIONOSTICS, INC.
K101831 07/01/2010 ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 BIONOSTICS, INC.
K131136 04/22/2013 GLUCOSE METER-CHECK SOLUTION FOR TAIDOC BIONOSTICS, INC.
K081403 05/19/2008 GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC.
K112352 08/16/2011 GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT BIONOSTICS, INC.
K112356 08/16/2011 GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE BIONOSTICS, INC.
K063398 11/09/2006 ESA LEADCARE II LEAD CONTROL BIONOSTICS, INC.
K103553 12/03/2010 LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION BIONOSTICS, INC.
K123851 12/14/2012 GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC.
K113764 12/21/2011 GLUCOSE METER-CHECK SOLUTION FOR INFOPIA BIONOSTICS, INC.
K123966 12/26/2012 GLUCOSE METER-CHECK SOLUTION FOR BAYER BIONOSTICS, INC.


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