Atlas FDA

LFR

73 FDA 510(k) clearances · Product code

118 daysmedian time to decision
307 days90th percentile
73clearances measured

FDA profile

Official device name
Glucose Dehydrogenase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 164 · 2022: 101 · 2023: 103 · 2024: 171 · 2025: 836 · 2026: 419
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
FreeStyle InsuLinx Blood Glucose Monotioring System (K152328)Abott Laboratories2015-09-17
ACCU-CHEK AVIVA EXPERT SYSTEM (K142089)Roche Diagnostics Corporation2014-12-17
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM (K133537)Eps Bio Technology Corp.2014-04-28
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (K131727)Ceragem Medisys, Inc.2014-02-28
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (K131366)Roche Diagnostics Operations, Inc.2013-10-11
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (K122688)Nova Biomedical Corporation2013-04-04
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS (K121433)Hmd Biomedical, Inc.2013-02-14
NOVA ONE BLOOD GLUCOSE MONITOR (K122435)Nova Biomedical Corporation2012-12-20
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K113314)Hmd Biomedical, Inc.2012-11-09
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (K121224)Taidoc Technology Corporation2012-09-19
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (K113307)Hmd Biomedical, Inc.2012-07-27
CONTOUR NEXT BLOOD GLUCOSE METER (K121190)Bayer Healthcare, LLC2012-07-26
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM (K120042)Taidoc Technology Corporation2012-05-22
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K121207)Eps Bio Technology Corp.2012-05-18
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM (K113768)Taidoc Technology Corporation2012-04-12
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM (K113243)Eps Bio Technology Corp.2012-03-28
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) (K110587)Bayer Healthcare, LLC2012-03-28
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (K110894)Bayer Healthcare2012-03-28
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM (K111268)Bayer Healthcare2012-03-06
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS (K111874)Abbott Laboratories2012-02-16
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K112901)Eps Bio Technology Corp.2011-12-23
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM (K101299)Roche Diagnostics2011-09-21
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM (K110637)Cilag GmbH International2011-09-07
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K112272)Eps Bio Technology Corp.2011-09-07
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM (K092688)Taidoc Technology Corporation2011-07-06
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 (K101037)Eps Bio Technology Corp.2011-05-23
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 (K083223)Abbott Diabetes Care, Inc.2009-04-16
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS (K070984)Abbott Diabetes Care, Inc.2007-11-01
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 (K060765)Hemocue AB2006-09-06
MODIFICATION TO ACCU-CHEK GO SYSTEM (K051592)Roche Diagnostics Corp.2005-09-02
ACCU-CHEK INTEGRA SYSTEM (K050872)Roche Diagnostics Corp.2005-05-02
ACCU-CHEK AVIVA SYSTEM (K043474)Roche Diagnostics Corp.2005-04-27
CLINICAL LABORATORY ANALYZING SYSTEM (K041230)Hemocue, Inc.2004-05-20
ACCU-CHEK GO SYSTEM (K040796)Roche Diagnostics Corp.2004-04-22
SENOVA(R) BLOOD GLUCOSE MONITOR (K032076)Chdiagnostics, LLC2003-09-30
ACCU-CHEK COMPACT TEST STRIP (K031755)Roche Diagnostics Corp.2003-07-03
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING (K022941)Abbott Laboratories2002-10-28
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY (K021960)Abbott Laboratories2002-08-16
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS (K004010)Roche Diagnostics Corp.2001-04-26
ACCU-CHEK INFORM METER (K003846)Roche Diagnostics Corp.2001-03-19
ACCU-CHEK COMFORT CURVE TEST STRIP (K010362)Roche Diagnostics Corp.2001-03-07
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 (K000582)Abbott Diabetes Care, Inc.2000-12-05
SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS (K001993)Abbott Laboratories2000-11-13
CONNECT DATA MANAGEMENT SYSTEM (K994433)Abbott Diabetes Care, Inc.2000-05-05
ACCU-CHEK COMPLETE METER (K000364)Roche Diagnostics Corp.2000-02-23
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM (K992684)Abbott Diabetes Care, Inc.2000-01-14
ACCU-CHEK SIMPLICITY SYSTEM (K993829)Roche Diagnostics Corp.1999-12-09
ACCU-CHEK HQ SYSTEM (K983047)Boehringer Mannheim Corp.1999-02-05
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS (K982089)Boehringer Mannheim Corp.1998-09-03
ACCU-CHEK COMFORT CURVE TEST STRIP (K982002)Boehringer Mannheim Corp.1998-09-02
ACCU-CHECK VOICEMATE (K982079)Boehringer Mannheim Corp.1998-08-28
ACCU-CHEK COMFORT CURVE TEST STRIPS (K980731)Boehringer Mannheim Corp.1998-05-22
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS (K973662)Boehringer Mannheim Corp.1997-12-15
GLUCOTREND BASIC SYSTEM (K972876)Boehringer Mannheim Corp.1997-10-09
HEMOCUE B-GLCOSE SYSTEM (K962415)Hemocue, Inc.1996-10-15
HEMOCUE B-GLUCOSE SYSTEM (K961311)Hemocue, Inc.1996-08-23
ACCU-CHEK ADVANTAGE TEST STRIPS (K954833)Boehringer Mannheim Corp.1996-02-15
GLUCOSE TEST ITEM NUMBER 97375/94 (K951750)Emd Chemicals, Inc.1995-09-06
ADVANTAGE TEST STRIPS (K951887)Boehringer Mannheim Corp.1995-08-24
GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM (K870708)Kyoto Daiichi Kagaku Co., Ltd.1988-02-02
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 (K874708)Em Diagnostic Systems, Inc.1987-12-18
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID (K860726)Trace Scientific , Ltd.1986-04-21
EMDS GLUCOSE TEST PACK ITEM 67656/95 (K855080)Em Diagnostic Systems, Inc.1986-02-11
ULTRACHEM GLUC-DH (K821867)Harleco Diagnostics1982-07-06
ULTRACHEM GLUC-DH, #65048 (K821463)Emd Chemicals, Inc.1982-06-02
ULTRACHEM GLUC-DH, #65048 (K821469)Emd Chemicals, Inc.1982-06-02
ULTRACHEM GLUC-DH (K813427)Harleco1981-12-31
ULTRACHEM GLUC-DH SET, ITEM #65048 (K813042)Harleco1981-11-10
ULTRACHEM GLUC-DH, ITEM NO. 65048 (K811202)Harleco1981-05-27
GLUCOSE (GDH) REAGENT (K791213)Gilford Diagnostics1979-08-10
KINETIC DETERMINATION OF UV GLUCOSE (K791110)The Dow Chemical Co.1979-08-03
BLOOD SUGAR (K781783)Gilford Diagnostics1978-12-04
UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS (K771102)The Dow Chemical Co.1977-11-22

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Every clearance here is in the API, with alerts when new ones post.