Bionostics, Inc.

FDA 510(k) & PMA Approved Devices — 49 products

Total Devices49

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K131136	GLUCOSE METER-CHECK SOLUTION FOR TAIDOC	JJX	2013-05-31	View
510(k)	K123851	GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK	JJX	2013-02-14	View
510(k)	K123966	GLUCOSE METER-CHECK SOLUTION FOR BAYER	JJX	2013-01-25	View
510(k)	K113764	GLUCOSE METER-CHECK SOLUTION FOR INFOPIA	JJX	2012-01-30	View
510(k)	K112352	GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT	JJX	2011-12-23	View
510(k)	K112356	GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE	JJX	2011-09-19	View
510(k)	K103553	LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION	JJX	2011-02-10	View
510(k)	K101831	ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800	OSL	2010-10-01	View
510(k)	K091914	OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION	JJX	2009-11-06	View
510(k)	K081478	RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS	JJX	2008-10-06	View
510(k)	K082395	GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002	JJX	2008-09-18	View
510(k)	K081403	GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK	JJX	2008-07-25	View
510(k)	K063398	ESA LEADCARE II LEAD CONTROL	DIF	2006-12-05	View
510(k)	K053327	OXICOM CONTROL	JJX	2006-01-26	View
510(k)	K050961	RNA1C CONTROL FOR NYCOCARD HBA1C	JJX	2005-05-13	View
510(k)	K050100	RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER	JJX	2005-02-25	View
510(k)	K032819	GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM	JJX	2003-10-20	View
510(k)	K032453	ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL	JJY	2003-08-28	View
510(k)	K022769	LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION	JJX	2002-11-13	View
510(k)	K021697	GLUCOSE CONTROL SOLUTION FOR BD LATITUDE	JJX	2002-07-12	View