Company ยท US
Bionostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2013. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 22 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 10 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 5 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 2 |
| DIF | Drug Mixture Control Materials | 1 |
| GLK | Control, Hematocrit | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JIS | Calibrator, Primary | 1 |
| JIT | Calibrator, Secondary | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 |
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | 1 |
| OSL | Control, Fecal Occult Blood | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 2013 | K131136 | GLUCOSE METER-CHECK SOLUTION FOR TAIDOC Bionostics, Inc. | JJX |
| Feb 14, 2013 | K123851 | GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK Bionostics, Inc. | JJX |
| Jan 25, 2013 | K123966 | GLUCOSE METER-CHECK SOLUTION FOR BAYER Bionostics, Inc. | JJX |
| Jan 30, 2012 | K113764 | GLUCOSE METER-CHECK SOLUTION FOR INFOPIA Bionostics, Inc. | JJX |
| Dec 23, 2011 | K112352 | GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT Bionostics, Inc. | JJX |
| Sep 19, 2011 | K112356 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE Bionostics, Inc. | JJX |
| Feb 10, 2011 | K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION Bionostics, Inc. | JJX |
| Oct 1, 2010 | K101831 | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 Bionostics, Inc. | OSL |
| Nov 6, 2009 | K091914 | OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION Bionostics, Inc. | JJX |
| Oct 6, 2008 | K081478 | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS Bionostics, Inc. | JJX |
| Sep 18, 2008 | K082395 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 Bionostics, Inc. | JJX |
| Jul 25, 2008 | K081403 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK Bionostics, Inc. | JJX |
| Dec 5, 2006 | K063398 | ESA LEADCARE II LEAD CONTROL Bionostics, Inc. | DIF |
| Jan 26, 2006 | K053327 | OXICOM CONTROL Bionostics, Inc. | JJX |
| May 13, 2005 | K050961 | RNA1C CONTROL FOR NYCOCARD HBA1C Bionostics, Inc. | JJX |
| Feb 25, 2005 | K050100 | RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER Bionostics, Inc. | JJX |
| Oct 20, 2003 | K032819 | GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM Bionostics, Inc. | JJX |
| Aug 28, 2003 | K032453 | ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL Bionostics, Inc. | JJY |
| Nov 13, 2002 | K022769 | LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION Bionostics, Inc. | JJX |
| Jul 12, 2002 | K021697 | GLUCOSE CONTROL SOLUTION FOR BD LATITUDE Bionostics, Inc. | JJX |
| Jul 12, 2002 | K021624 | RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 Bionostics, Inc. | JJX |
| Jun 25, 2002 | K021930 | MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL Bionostics, Inc. | JJY |
| Jun 24, 2002 | K021924 | MEDICA EASYQC HEMATOCRIT CONTROL Bionostics, Inc. | GLK |
| Oct 24, 2001 | K013147 | GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE Bionostics, Inc. | JJX |
| Aug 28, 2001 | K012431 | COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 Bionostics, Inc. | JJY |
| Aug 27, 2001 | K012430 | MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 Bionostics, Inc. | JJX |
| Sep 18, 2000 | K002540 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS Bionostics, Inc. | JJX |
| Feb 28, 2000 | K000318 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Bionostics, Inc. | JJX |
| Feb 12, 1998 | K980178 | OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY Bionostics, Inc. | JJY |
| Aug 28, 1997 | K972868 | TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL Bionostics, Inc. | JJY |
| Mar 1, 1996 | K955630 | RNA MEDICAL HEMAT CONTROL Bionostics, Inc. | JJR |
| Feb 22, 1995 | K950399 | RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL Bionostics, Inc. | JJY |
| Sep 14, 1994 | K943754 | BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT Bionostics, Inc. | JJY |
| Jun 30, 1992 | K922357 | RNA MEDICAL'S EQUIL 55 Bionostics, Inc. | JJS |
| Jun 26, 1992 | K922386 | RNA MEDICAL TONOMETER Bionostics, Inc. | LCH |
| Sep 27, 1991 | K913133 | CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) Bionostics, Inc. | JJY |
| May 22, 1991 | K911755 | CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE Bionostics, Inc. | JJY |
| Nov 28, 1990 | K904698 | SECONDARY CALIBRATORS Bionostics, Inc. | JIT |
| Oct 12, 1990 | K904335 | SECONDARY CALIBRATORS Bionostics, Inc. | JGS |
| May 27, 1988 | K880447 | MULTI-FUNCTION BLOOD GAS CONTROL Bionostics, Inc. | JJY |
| Mar 24, 1988 | K880710 | PROTEIN BASE ISE CONTROL Bionostics, Inc. | JJR |
| Dec 14, 1987 | K874408 | MULTI-FUNCTION BLOOD GAS CONTROL Bionostics, Inc. | JJS |
| May 20, 1985 | K851911 | MULTI FUNCTION BLOOD GAS CONTROL Bionostics, Inc. | JJS |
| Jun 14, 1984 | K841783 | BLOOD GAS CONTROL, LEVEL I(ACIDOSIS Bionostics, Inc. | JJS |
| Apr 17, 1984 | K840843 | POTASSIUM CHLORIDE TABLETS Bionostics, Inc. | CHL |
| Mar 23, 1984 | K840300 | FLUSH SOLUTION CONCENTRATE-BLOOD GAS Bionostics, Inc. | CHL |
| Mar 23, 1984 | K840299 | PH ELECTRODE CALIBRATING BUFFERS-BLOOD Bionostics, Inc. | JIS |
| Nov 28, 1983 | K833146 | AQUEOUS BLOOD GAS CONTROL Bionostics, Inc. | JJS |
| Jul 18, 1983 | K831872 | CALIBRATOR 282 Bionostics, Inc. | KRZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||