Medical Device Manufacturer · US , Mchenry , IL

Bionostics, Inc.

49 submissions · 49 cleared · Since 1983
49
Total
49
Cleared
0
Denied

Bionostics, Inc. — FDA 510(k) Submissions

Bionostics, Inc. has submitted 49 FDA 510(k) premarket notifications since 1983, of which 49 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Multi-analyte Controls, All Kinds (assayed), Controls For Blood-gases, (assayed And Unassayed), Electrolyte Controls (assayed And Unassayed), Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph . Use the specialty filter in the sidebar to narrow results.

49 devices
1–25 of 49
GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
K131136 · JJX Single (specified)... · Chemistry
May 2013 39d
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
K123851 · JJX Single (specified)... · Chemistry
Feb 2013 62d
GLUCOSE METER-CHECK SOLUTION FOR BAYER
K123966 · JJX Single (specified)... · Chemistry
Jan 2013 30d
GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
K113764 · JJX Single (specified)... · Chemistry
Jan 2012 40d
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
K112352 · JJX Single (specified)... · Chemistry
Dec 2011 129d
GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
K112356 · JJX Single (specified)... · Chemistry
Sep 2011 34d
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
K103553 · JJX Single (specified)... · Chemistry
Feb 2011 69d
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
K101831 · OSL Control, Fecal Occult Blood · Hematology
Oct 2010 92d
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
K091914 · JJX Single (specified)... · Chemistry
Nov 2009 129d
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
K081478 · JJX Single (specified)... · Chemistry
Oct 2008 132d
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
K082395 · JJX Single (specified)... · Chemistry
Sep 2008 30d
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
K081403 · JJX Single (specified)... · Chemistry
Jul 2008 67d
ESA LEADCARE II LEAD CONTROL
K063398 · DIF Drug Mixture Control... · Toxicology
Dec 2006 26d
OXICOM CONTROL
K053327 · JJX Single (specified)... · Chemistry
Jan 2006 56d
RNA1C CONTROL FOR NYCOCARD HBA1C
K050961 · JJX Single (specified)... · Chemistry
May 2005 25d
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
K050100 · JJX Single (specified)... · Chemistry
Feb 2005 38d
GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM
K032819 · JJX Single (specified)... · Chemistry
Oct 2003 40d
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
K032453 · JJY Multi-analyte Controls,... · Chemistry
Aug 2003 17d
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
K022769 · JJX Single (specified)... · Chemistry
Nov 2002 84d
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
K021624 · JJX Single (specified)... · Chemistry
Jul 2002 57d
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
K021697 · JJX Single (specified)... · Chemistry
Jul 2002 51d
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
K021930 · JJY Multi-analyte Controls,... · Chemistry
Jun 2002 13d
MEDICA EASYQC HEMATOCRIT CONTROL
K021924 · GLK Control, Hematocrit · Hematology
Jun 2002 13d
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147 · JJX Single (specified)... · Chemistry
Oct 2001 34d
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
K012431 · JJY Multi-analyte Controls,... · Chemistry
Aug 2001 28d
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