Bionostics, Inc.
Bionostics, Inc. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2013.
Top product codes for Bionostics, Inc.
Recent clearances by Bionostics, Inc.
- K131136 — GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
- K123851 — GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
- K123966 — GLUCOSE METER-CHECK SOLUTION FOR BAYER
- K113764 — GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
- K112352 — GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
- K112356 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
- K103553 — LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
- K101831 — ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
- K091914 — OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
- K081478 — RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
- K082395 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
- K081403 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
- K063398 — ESA LEADCARE II LEAD CONTROL
- K053327 — OXICOM CONTROL
- K050961 — RNA1C CONTROL FOR NYCOCARD HBA1C
- K050100 — RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
- K032819 — GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM
- K032453 — ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
- K022769 — LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
- K021624 — RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
- K021697 — GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
- K021930 — MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
- K021924 — MEDICA EASYQC HEMATOCRIT CONTROL
- K013147 — GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
- K012431 — COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
- K012430 — MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
- K002540 — BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS
- K000318 — BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K980178 — OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
- K972868 — TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
- K955630 — RNA MEDICAL HEMAT CONTROL
- K950399 — RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL
- K943754 — BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT
- K922357 — RNA MEDICAL'S EQUIL 55
- K922386 — RNA MEDICAL TONOMETER
- K913133 — CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
- K911755 — CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE
- K904698 — SECONDARY CALIBRATORS
- K904335 — SECONDARY CALIBRATORS
- K880447 — MULTI-FUNCTION BLOOD GAS CONTROL
- K880710 — PROTEIN BASE ISE CONTROL
- K874408 — MULTI-FUNCTION BLOOD GAS CONTROL
- K851911 — MULTI FUNCTION BLOOD GAS CONTROL
- K841783 — BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
- K840843 — POTASSIUM CHLORIDE TABLETS
- K840299 — PH ELECTRODE CALIBRATING BUFFERS-BLOOD
- K840300 — FLUSH SOLUTION CONCENTRATE-BLOOD GAS
- K833146 — AQUEOUS BLOOD GAS CONTROL
- K831872 — CALIBRATOR 282
Data sourced from openFDA. This site is unofficial and independent of the FDA.