Bionostics, Inc.
Medical device manufacturer in Devens, MA.
49510(k) clearances
0PMA approvals
0recalls
Device types
- JJX Single (Specified) Analyte Controls… 22
- JJY Multi-Analyte Controls, All Kinds (Assayed) 10
- JJS Controls For Blood-Gases, (Assayed And… 5
- CHL Electrode Measurement, Blood-Gases (Pco2… 2
- JJR Electrolyte Controls (Assayed And Unassayed) 2
- KRZ Calibrator For Hemoglobin And Hematocrit… 1
- JIS Calibrator, Primary 1
- JGS Electrode, Ion Specific, Sodium 1
- JIT Calibrator, Secondary 1
- LCH Tonometer (Calibration And Q.C. Of… 1
- GLK Control, Hematocrit 1
- DIF Drug Mixture Control Materials 1
- OSL Control, Fecal Occult Blood 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K131136 | Glucose Meter-Check Solution for TaidocJJX · Traditional | 05/31/2013SE |
| K123851 | Glucose Meter-Check Solution for Roche Accu-ChekJJX · Traditional | 02/14/2013SE |
| K123966 | Glucose Meter-Check Solution for BayerJJX · Traditional | 01/25/2013SE |
| K113764 | Glucose Meter-Check Solution for InfopiaJJX · Traditional | 01/30/2012SE |
| K112352 | Glucose Meter-Check Control for Nipro TrueresultJJX · Traditional | 12/23/2011SE |
| K112356 | Glucose Meter-Check Control Solution for Agamatrix WavesenseJJX · Traditional | 09/19/2011SE |
| K103553 | Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionJJX · Traditional | 02/10/2011SE |
| K101831 | Enterix Insurefit Fob Controls, Model 16800OSL · Traditional | 10/01/2010SE |
| K091914 | Omnis Health Embrace Glucose Control SolutionJJX · Traditional | 11/06/2009SE |
| K081478 | RNA Medical Glucose and B-Ketone Calibration Verification ControlsJJX · Traditional | 10/06/2008SE |
| K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002JJX · Traditional | 09/18/2008SE |
| K081403 | Glucose Meter-Check Control Solution for Roche Accu-ChekJJX · Traditional | 07/25/2008SE |
| K063398 | Esa Leadcare II Lead ControlDIF · Traditional | 12/05/2006SE |
| K053327 | Oxicom ControlJJX · Traditional | 01/26/2006SE |
| K050961 | RNA1C Control for Nycocard HBA1CJJX · Traditional | 05/13/2005SE |
| K050100 | RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ AnalyzerJJX · Traditional | 02/25/2005SE |
| K032819 | Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose…JJX · Traditional | 10/20/2003SE |
| K032453 | Roche Combitrol and Autotrol Plus B Multi Analyte ControlJJY · Traditional | 08/28/2003SE |
| K022769 | Lifescan Onetouch Ultra Control SolutionJJX · Traditional | 11/13/2002SE |
| K021697 | Glucose Control Solution for BD LatitudeJJX · Traditional | 07/12/2002SE |
| K021624 | RNA GL4 Glucose Calibration Verification Control, Model RNA CVC GL4JJX · Traditional | 07/12/2002SE |
| K021930 | Medica Easyqc Blood Gas/Electrolyte ControlJJY · Traditional | 06/25/2002SE |
| K021924 | Medica Easyqc Hematocrit ControlGLK · Traditional | 06/24/2002SE |
| K013147 | Glucose Control Solution for Therasense FreestyleJJX · Traditional | 10/24/2001SE |
| K012431 | Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control…JJY · Traditional | 08/28/2001SE |
| K012430 | Multi-Meter Glucose Calibration Verification Material, Model RNA GL3JJX · Traditional | 08/27/2001SE |
| K002540 | Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test…JJX · Traditional | 09/18/2000SE |
| K000318 | Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood…JJX · Traditional | 02/28/2000SE |
| K980178 | Oxyhemoglobin Control for Co-OximetryJJY · Traditional | 02/12/1998SE |
| K972868 | Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine ControlJJY · Traditional | 08/28/1997SE |
| K955630 | RNA Medical Hemat ControlJJR · Traditional | 03/01/1996SE |
| K950399 | RNA Medical's Equil Plus with Glucose ControlJJY · Traditional | 02/22/1995SE |
| K943754 | Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control ProductJJY · Traditional | 09/14/1994SE |
| K922357 | RNA Medical's Equil 55JJS · Traditional | 06/30/1992SE |
| K922386 | RNA Medical TonometerLCH · Traditional | 06/26/1992SE |
| K913133 | Chality Control Material (Assayed & Unassayed)JJY · Traditional | 09/27/1991SE |
| K911755 | Control for Ph,Blood Gases,Eletrolytes,GlucoseJJY · Traditional | 05/22/1991SE |
| K904698 | Secondary CalibratorsJIT · Traditional | 11/28/1990SE |
| K904335 | Secondary CalibratorsJGS · Traditional | 10/12/1990SE |
| K880447 | Multi-Function Blood Gas ControlJJY · Traditional | 05/27/1988SE |
| K880710 | Protein Base Ise ControlJJR · Traditional | 03/24/1988SE |
| K874408 | Multi-Function Blood Gas ControlJJS · Traditional | 12/14/1987SE |
| K851911 | Multi Function Blood Gas ControlJJS · Traditional | 05/20/1985SE |
| K841783 | Blood Gas Control, Level I(AcidosisJJS · Traditional | 06/14/1984SE |
| K840843 | Potassium Chloride TabletsCHL · Traditional | 04/17/1984SE |
| K840300 | Flush Solution Concentrate-Blood GasCHL · Traditional | 03/23/1984SE |
| K840299 | PH Electrode Calibrating Buffers-BloodJIS · Traditional | 03/23/1984SE |
| K833146 | Aqueous Blood Gas ControlJJS · Traditional | 11/28/1983SE |
| K831872 | Calibrator 282KRZ · Traditional | 07/18/1983SE |