FDA.reportPublic FDA data

BIONOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12206491220649BIONOSTICS, INC.1N2026-01-017 JACKSON RD. Devens MA US 01434

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
303542046724335K984261SURESTEP BLOOD GLUCOSE MONITORING SYSTEMCGA1999-05-21
303541595964019K983475HEMOCHRON RESPONSEKQG1999-05-03
303541741188639K982303PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST STCGA1998-12-08
303541824569714K980178OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRYJJY1998-02-12
303541156237161K974822AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROLJJY1998-01-22
303541080628556K972868TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROLJJY1997-08-28
303541975420511K970556SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEMCGA1997-05-12
303541799382188K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4GLK1996-07-26
303541367106057K955630RNA MEDICAL HEMAT CONTROLJJR1996-03-01
303541623203733K950399RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROLJJY1995-02-22
303541178268033K946224CERTAIN(R) ELITE LEVEL 1, 2 AND 3JJS1995-01-30
303542036506138K944691ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR IIGGN1995-03-15
303541666247673K943754BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCTJJY1994-09-14
303541134643737K934907860 MEASURMENT SYSTEMCHL1994-01-03
303541664572031K913133CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)JJY1991-09-27
303541713977713K911755CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSEJJY1991-05-22
303541189423436K882481HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/IIGGN1988-08-30
303541864053111K880710PROTEIN BASE ISE CONTROLJJR1988-03-24
303541552225949K880447MULTI-FUNCTION BLOOD GAS CONTROLJJY1988-05-27
303541505208343K874408MULTI-FUNCTION BLOOD GAS CONTROLJJS1987-12-14
303541239946332K870036BAYER HEALTHCARE RAPIDQC PLUSJJS1987-01-14
303541611715120K853776MSI-HB HEMOGLOBIN CONTROLJPK1985-09-19
303542051178708K841783BLOOD GAS CONTROL, LEVEL I(ACIDOSISJJS1984-06-14
303541895355608K833146AQUEOUS BLOOD GAS CONTROLJJS1983-11-28
303541687164491K832028CERTAIN HB CO-OXIMETER CONTROLJJS1983-07-18
303541137698303K170064GLUCOCARD W Blood Glucose Monitoring SystemNBW2017-08-16
303541019026504K141829GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEMNBW2014-09-24
303541519178040K131136GLUCOSE METER-CHECK SOLUTION FOR TAIDOCJJX2013-05-31
303541024028731K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEMCGA2014-06-30
303541629963130K123090GLB BENECHECK PREMIUM GLU MONITORING SYSTEMNBW2013-11-22
303541974446938K121679ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEMNBW2012-10-11
303541482420539K120989TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEMNBW2013-04-24
303541920879007K120977DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MICGGN2013-07-03
303541349444930K120921CLEVER CHOICECGA2012-08-21
303541198681908K120183ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEMNBW2012-05-11
303541172112663K113764GLUCOSE METER-CHECK SOLUTION FOR INFOPIAJJX2012-01-30
303541748806678K113670ELEMENT BLOOD GLUCOSE MONITORING SYSTEMCGA2012-05-08
303541793777004K113636BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)CGA2013-03-08
303541659772060K113135UNISTRIP 1NBW2013-11-06
303541136053835K112356GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSEJJX2011-09-19
303541220820989K112352GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULTJJX2011-12-23
303541679734233K111456MEDISIGN BLOOD GLUCOSE MONITORING SYSTEMNBW2012-02-28
303541271055814K103553LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTIONJJX2011-02-10
303541964554742K103544IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV DNBW2011-12-07
303542020250829K102316GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEMCGA2011-10-07
303541710234832K101831ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800OSL2010-10-01
303541622343364K093941CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265CGA2010-03-26
303541648056794K093745ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMNBW2011-02-11
303541208681648K093724FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTIONJJX2010-07-29
303541787001092K093262AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEMNBW2010-07-13
303541962555898K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMCGA2009-11-24
303541336379464K091914OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTIONJJX2009-11-06
303541722540526K091711S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023LCP2009-12-11
303541842021201K090389AP-1000 BLOOD GLUCOSE MONITORING SYSTEMNBW2009-07-14
303541821957703K083184TEARLAB OSMOLARITY SYSTEMOND2009-05-14
303541244999227K082395GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002JJX2008-09-18
303541405774741K081714FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEMCGA2008-07-25
303541130349745K081478RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLSJJX2008-10-06
303541371642865K081403GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEKJJX2008-07-25
303541091745496K080641TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81NBW2008-08-19
303541322250225K073118PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2008-03-05
303541989308262K072039ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223FNBW2007-10-03
303541212284595K070585ACCU-CHEK PERFORMA SYSTEMNBW2007-05-25
303541581421373K070524MICRODOT BLOOD GLUCOSE MONITORING SYSTEMNBW2007-06-22
303541182798869K063398ESA LEADCARE II LEAD CONTROLDIF2006-12-05
303542037021782K062347ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEMNBW2006-11-22
303541550901128K062235EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYSTNBW2006-09-19
303541272646453K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080NBW2006-09-11
303541030136854K061974GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRITCHL2006-09-15
303541501574481K053327OXICOM CONTROLJJX2006-01-26
303541839550972K052762LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067NBW2006-01-23
303541826925171K051514ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002NBW2005-10-04
303541138546816K050961RNA1C CONTROL FOR NYCOCARD HBA1CJJX2005-05-13
303542006538910K050100RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZERJJX2005-02-25
303542071611327K043474ACCU-CHEK AVIVA SYSTEMLFR2005-04-27
303541975054117K043245EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEMCGA2005-04-29
303541278545178K042678RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMNBW2005-01-03
303541874740852K042005ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222NBW2004-08-27
303541428802455K041107TAIDOC CHECKNBW2004-06-18
303541878848506K040796ACCU-CHEK GO SYSTEMLFR2004-04-22
303541302325165K032453ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROLJJY2003-08-28
303541898109507K031472ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPSCGA2003-08-05
303541922880079K030703TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPSNBW2003-07-11
303541202562360K022158IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)CGA2002-09-10
303541660616969K021930MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROLJJY2002-06-25
303541784703035K021924MEDICA EASYQC HEMATOCRIT CONTROLGLK2002-06-24
303541566440275K021697GLUCOSE CONTROL SOLUTION FOR BD LATITUDEJJX2002-07-12
303541094374472K021624RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4JJX2002-07-12
303541258001742K020798HEMOCHRON JR. SIGNATURE +JPA2002-03-28
303541892486388K020232HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEMCGA2002-02-12
303541333563682K013147GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLEJJX2001-10-24
303541170536043K012431COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3JJY2001-08-28
303541124248610K004010ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLSLFR2001-04-26
303541656175917K003239LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506JJS2000-11-30
303541588644200K002866LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574JJS2000-09-25
303541404512488K002535LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513JJS2000-08-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW342017-08-16
JJY192003-08-28
CGA182014-06-30
JJX182013-05-31
JJS122000-11-30
LFR42005-04-27
GGN32013-07-03
CHL32006-09-15
GLK32002-06-24
OSL22010-10-01
JJR21996-03-01
JPK21985-09-19
LCP12009-12-11
OND12009-05-14
DIF12006-12-05
JPA12002-03-28
KQG11999-05-03

PMN#

48 records. Showing 1-40. Next