Bionostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
49
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K131136GLUCOSE METER-CHECK SOLUTION FOR TAIDOCMay 31, 2013
K123851GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEKFebruary 14, 2013
K123966GLUCOSE METER-CHECK SOLUTION FOR BAYERJanuary 25, 2013
K113764GLUCOSE METER-CHECK SOLUTION FOR INFOPIAJanuary 30, 2012
K112352GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULTDecember 23, 2011
K112356GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSESeptember 19, 2011
K103553LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTIONFebruary 10, 2011
K101831ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800October 1, 2010
K091914OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTIONNovember 6, 2009
K081478RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLSOctober 6, 2008
K082395GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002September 18, 2008
K081403GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEKJuly 25, 2008
K063398ESA LEADCARE II LEAD CONTROLDecember 5, 2006
K053327OXICOM CONTROLJanuary 26, 2006
K050961RNA1C CONTROL FOR NYCOCARD HBA1CMay 13, 2005
K050100RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZERFebruary 25, 2005
K032819GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEMOctober 20, 2003
K032453ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROLAugust 28, 2003
K022769LIFESCAN ONETOUCH ULTRA CONTROL SOLUTIONNovember 13, 2002
K021624RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4July 12, 2002