BIONOSTICS, INC.

FDA Device Registration & Listing · Devens, MA, US · Registration 1220649

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1220649
FEI Number
1220649
Entity Name
BIONOSTICS, INC.
City/State/Country
Devens, MA, US
Establishment Address
7 JACKSON RD., Devens, MA 01434, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BIONOSTICS, INC. (Owner Number: 1220649)
Owner / Operator Contact Address
7 JACKSON RD., --, Devens, MA 01434, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K961807
PMA Number
N/A

All Registered Proprietary Names

ARKRAY Assure Dose Glucose Control Solution TRUEmetrix Glucose Control JJX GlucoVitaal HbA1c Control Assure Control Control Solution ARKRAY GLUCOCARD glucose control solution PHLORINGDH APOC i-STAT CHEM 8+ Control APOC i-STAT 1 Calibration Verification Kit APOC i-STAT TriControls Calibration Verification Kit APOC i-STAT CHEM 8+ Calibration Verifier Kit APOC i-STAT 1 Controls JJX Advocate Glucose Control directCheck Whole Blood ACT+ Control directCheck Whole Blood ACT-Low Range Control JJX Siemens RapidLab High Glucose Control OPTI Medical OPTI-Check PLUS Control One Touch Select Plus Control Solution Assure Control – Control Solution GLK Instrumentation Lab GEM Crit PVP Kit GLK Instrumentation Lab GEM Crit Check JJY Instrumentation Lab GEM Creatine Control JJX TearLab Osmolarity Control UniStrip Glucose Control Siemens RapidQC CVM Siemens RapidQC COMPLETE Control GMate Voice Glucose Control HepCheck Whole Blood Control directCheck High Dose Thrombin Time (HiTT) Control directCheck PRO Protime Control Contour Next Control Solution JJX Roche AccuCheck Performa Glucose Control Solution RNA Medical QCHGB Control Glucose Control for Broadmaster Biotech BGMS JJX Bionime Rightest Glucose Control Solution JJX Bionime G700 Glucose Control Solution directCheck Whole Blood Citrated PT/APTT Control GEM Check APTT Control directCheck Whole Blood Citrated PT Control GEM Check ACT Control directCheck Whole Blood PT Control GEM Check Citrated PT Control GEM Check PT Control GEM Check ACT Low Range Control directCheck Whole Blood APTT Control Waters OXYCOM tHb/SO2 Control RNA Medical CC527 Control JJX Clever Choice Glucose Control JJX LifeScan OneTouch Verio Glucose Control Solution Roche AUTOTROL PLUS B Control Roche COMBITROL PLUS B Control Assure Dose Control Contour TS Controls MEDICA EasyQC Hematocrit Control JJY Instrumentation Lab GEM Crit Check Control JJY Instrumentation Lab GEM CVP Kit JJY Instrumentation Lab Gem Crit PVP Kit JJY Instrumentation Lab GEM PVP Kit JJX Easy Check Glucose Control Assure Dose Glucose Control EMPECS Glucose Control Enterix iFOB Control Roche AUTOTROL TS PLUS Control Roche COMBITROL TS PLUS Control BIO-RAD LiquiCheck Blood Gas Control JJX FORA Glucose Control ESA LeadCare II Lead Control RNA Medical QC823 Range Control RNA Medical CVC123 CVC Kit RNA Medical QC823 Control JJX Arkray Assure Dose Glucose Control ACCU-CHEK Inform II Linearity Test Kit ACCU-CHEK Inform II Controls LifeScan GlucoTouch Control Solution LifeScan OneTouch Select Glucose Control Solution LifeScan OneTouch Horizon Glucose Control Solution LifeScan OneTouch Vita Glucose Control Solution LifeScan OneTouch Ultra Glucose Control Solution LifeScan Verio Glucose Control Solution JJX ANDON Health Glucose Control JJX BeneCheck Glucose Control Solution Siemens RapidQC Hematocrit Control Siemens RapidQC Hematocrit CVM Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-01-20
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-01-20
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2014-01-20
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-12-13
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2013-12-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-12-13
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-01-05
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-01-05
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2015-01-05
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-06-10
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-01-05
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2015-01-05
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-04-26
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2009-10-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-09
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-09
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2013-12-13
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2011-11-08
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-10-24
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2021-05-04
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2011-11-08
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2011-11-08
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-11-08
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2011-11-08
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2011-11-08
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2011-11-08
GLK Control, Hematocrit Hematology Class 2 864.8625 2011-11-08
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2011-11-08
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2011-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2011-11-08
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2011-11-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-08
OND Osmolality Of Tears Clinical Chemistry Class 1 862.1540 2011-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2018-11-21
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2018-11-21
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-10-25
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2013-12-13
KQG Instrument, Coagulation Hematology Class 2 864.5400 2013-12-13
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2021-07-29
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-08
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2006-07-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-08
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2013-12-13
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-10-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2007-12-18
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-08
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2009-10-28
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2026-04-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2026-04-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2026-04-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-01-25
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2017-01-25
GLK Control, Hematocrit Hematology Class 2 864.8625 2009-10-28
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
GFS Standards And Controls, Hemoglobin, Normal And Abnormal Hematology Class 2 864.8625 2011-11-08
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-09
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-04-22
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-04-22
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2013-04-22
OSL Control, Fecal Occult Blood Hematology Class 2 864.6550 2011-03-29
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2009-10-28
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-10-24
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-09
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2011-11-09
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2009-10-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2007-12-18
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-09
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-10-31
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-10-31
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-10-31
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-03-29
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-11-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-11-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-01-05
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-01-05
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2015-01-05
GLK Control, Hematocrit Hematology Class 2 864.8625 2011-10-25

Official Correspondent

Yifei Wang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIONOSTICS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220649. Last updated year: 2026. Please use registration number 1220649 when referencing this establishment in official correspondence.
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