Bionostics, Inc.
Devens, MA, US
BIONOSTICS, INC. appears in FDA device records in Devens, MA. FDA records list 49 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 49 510(k) clearances for Bionostics, Inc. between 1983 and 2013. The busiest year on record is 2002, with 5. The most recent is 2013, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 5 |
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131136 | GLUCOSE METER-CHECK SOLUTION FOR TAIDOC | JJX | Substantially Equivalent | |
| K123851 | GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK | JJX | Substantially Equivalent | |
| K123966 | GLUCOSE METER-CHECK SOLUTION FOR BAYER | JJX | Substantially Equivalent | |
| K113764 | GLUCOSE METER-CHECK SOLUTION FOR INFOPIA | JJX | Substantially Equivalent | |
| K112352 | GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT | JJX | Substantially Equivalent | |
| K112356 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE | JJX | Substantially Equivalent | |
| K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION | JJX | Substantially Equivalent | |
| K101831 | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 | OSL | Substantially Equivalent | |
| K091914 | OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION | JJX | Substantially Equivalent | |
| K081478 | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS | JJX | Substantially Equivalent | |
| K082395 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 | JJX | Substantially Equivalent | |
| K081403 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK | JJX | Substantially Equivalent | |
| K063398 | ESA LEADCARE II LEAD CONTROL | DIF | Substantially Equivalent | |
| K053327 | OXICOM CONTROL | JJX | Substantially Equivalent | |
| K050961 | RNA1C CONTROL FOR NYCOCARD HBA1C | JJX | Substantially Equivalent | |
| K050100 | RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER | JJX | Substantially Equivalent | |
| K032819 | GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM | JJX | Substantially Equivalent | |
| K032453 | ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL | JJY | Substantially Equivalent | |
| K022769 | LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION | JJX | Substantially Equivalent | |
| K021697 | GLUCOSE CONTROL SOLUTION FOR BD LATITUDE | JJX | Substantially Equivalent | |
| K021624 | RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 | JJX | Substantially Equivalent | |
| K021930 | MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL | JJY | Substantially Equivalent | |
| K021924 | MEDICA EASYQC HEMATOCRIT CONTROL | GLK | Substantially Equivalent | |
| K013147 | GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE | JJX | Substantially Equivalent | |
| K012431 | COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 | JJY | Substantially Equivalent | |
| K012430 | MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 | JJX | Substantially Equivalent | |
| K002540 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS | JJX | Substantially Equivalent | |
| K000318 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | JJX | Substantially Equivalent | |
| K980178 | OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY | JJY | Substantially Equivalent | |
| K972868 | TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL | JJY | Substantially Equivalent | |
| K955630 | RNA MEDICAL HEMAT CONTROL | JJR | Substantially Equivalent | |
| K950399 | RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL | JJY | Substantially Equivalent | |
| K943754 | BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT | JJY | Substantially Equivalent | |
| K922357 | RNA MEDICAL'S EQUIL 55 | JJS | Substantially Equivalent | |
| K922386 | RNA MEDICAL TONOMETER | LCH | Substantially Equivalent | |
| K913133 | CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) | JJY | Substantially Equivalent | |
| K911755 | CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE | JJY | Substantially Equivalent | |
| K904698 | SECONDARY CALIBRATORS | JIT | Substantially Equivalent | |
| K904335 | SECONDARY CALIBRATORS | JGS | Substantially Equivalent | |
| K880447 | MULTI-FUNCTION BLOOD GAS CONTROL | JJY | Substantially Equivalent | |
| K880710 | PROTEIN BASE ISE CONTROL | JJR | Substantially Equivalent | |
| K874408 | MULTI-FUNCTION BLOOD GAS CONTROL | JJS | Substantially Equivalent | |
| K851911 | MULTI FUNCTION BLOOD GAS CONTROL | JJS | Substantially Equivalent | |
| K841783 | BLOOD GAS CONTROL, LEVEL I(ACIDOSIS | JJS | Substantially Equivalent | |
| K840843 | POTASSIUM CHLORIDE TABLETS | CHL | Substantially Equivalent | |
| K840300 | FLUSH SOLUTION CONCENTRATE-BLOOD GAS | CHL | Substantially Equivalent | |
| K840299 | PH ELECTRODE CALIBRATING BUFFERS-BLOOD | JIS | Substantially Equivalent | |
| K833146 | AQUEOUS BLOOD GAS CONTROL | JJS | Substantially Equivalent | |
| K831872 | CALIBRATOR 282 | KRZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220649 | 1220649 | BIONOSTICS, INC. | 7 JACKSON RD., Devens, MA 01434 US | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- GHSAssay, Carboxyhemoglobin
- JQPCalculator/Data Processing Module, For Clinical Use
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- JISCalibrator, Primary
- JITCalibrator, Secondary
- OSLControl, Fecal Occult Blood
- GLKControl, Hematocrit
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- DIFDrug Mixture Control Materials
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- JJRElectrolyte Controls (Assayed And Unassayed)
- LFRGlucose Dehydrogenase, Glucose
- CGAGlucose Oxidase, Glucose
- KQGInstrument, Coagulation
- GKFInstrument, Hematocrit, Automated
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- ONDOsmolality Of Tears
- GGNPlasma, Coagulation Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- GFSStandards And Controls, Hemoglobin, Normal And Abnormal
- GKRSystem, Hemoglobin, Automated
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- NBWSystem, Test, Blood Glucose, Over The Counter
- LCHTonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
- GIOTube, Collection, Capillary Blood
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain