Data / Medical devices / United States / Bionostics, Inc.
Bionostics, Inc.: FDA-registered device maker in Devens, MA, United States, 27 510(k) clearances
Bionostics, Inc. is registered with the FDA (registration 1220649) in Devens, MA, United States. It lists 27 device types. The FDA files 27 510(k) clearances under its listings, the newest dated September 24, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1220649
- Address
- 7 Jackson RD., Devens, MA, United States, 01434
- Owner or operator
- BIONOSTICS, INC. (1220649)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 3, 2006
- Registered through
- 2026
- Brand names listed
- ACCU-CHEK Inform II Controls, ACCU-CHEK Inform II Linearity Test Kit, APOC i-STAT 1 Calibration Verification Kit, APOC i-STAT 1 Controls, APOC i-STAT CHEM 8+ Calibration Verifier Kit, APOC i-STAT CHEM 8+ Control, APOC i-STAT TriControls Calibration Verification Kit, ARKRAY Assure Dose Glucose Control Solution and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 24, 2014 | K141829 | GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Ceragem Medisys, Inc. | accessdata.fda.gov |
| November 6, 2013 | K113135 | UNISTRIP 1 | NBW | Substantially Equivalent | Unistrip Technologies, LLC | accessdata.fda.gov |
| August 21, 2012 | K120921 | CLEVER CHOICE | CGA | Substantially Equivalent | Simple Diagnostics, Inc. | accessdata.fda.gov |
| February 10, 2011 | K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION | JJX | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101831 | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 | OSL | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| March 26, 2010 | K093941 | CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 | CGA | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| July 14, 2009 | K090389 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Bestgen Biotech Corp. | accessdata.fda.gov |
| October 6, 2008 | K081478 | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS | JJX | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| July 25, 2008 | K081714 | FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | CGA | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| October 3, 2007 | K072039 | ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| June 22, 2007 | K070524 | MICRODOT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Cambridge Sensors Limited | accessdata.fda.gov |
| May 25, 2007 | K070585 | ACCU-CHEK PERFORMA SYSTEM | NBW | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| November 22, 2006 | K062347 | ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| September 19, 2006 | K062235 | EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| April 27, 2005 | K043474 | ACCU-CHEK AVIVA SYSTEM | LFR | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
| August 30, 2000 | K002535 | LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 | JJS | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 21, 2000 | K002120 | LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 | JJS | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| June 19, 2000 | K001632 | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 | JJY | Substantially Equivalent | Avl Scientific Corp. | accessdata.fda.gov |
| February 12, 1998 | K980178 | OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY | JJY | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| January 22, 1998 | K974822 | AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL | JJY | Substantially Equivalent | Avl Scientific Corp. | accessdata.fda.gov |
| August 28, 1997 | K972868 | TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL | JJY | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| July 26, 1996 | K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | GLK | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| September 14, 1994 | K943754 | BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT | JJY | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| January 3, 1994 | K934907 | 860 MEASURMENT SYSTEM | CHL | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| September 27, 1991 | K913133 | CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) | JJY | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| May 27, 1988 | K880447 | MULTI-FUNCTION BLOOD GAS CONTROL | JJY | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| September 19, 1985 | K853776 | MSI-HB HEMOGLOBIN CONTROL | JPK | Substantially Equivalent | Medical Specialties, Inc. | accessdata.fda.gov |
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Updated September 24, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.