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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