FDA Product Code
FDA Product Code LFR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 73 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring System | Abott Laboratories | 2015-09-17 | Special | PDF ↗ |
| K142089 | ACCU-CHEK AVIVA EXPERT SYSTEM | Roche Diagnostics Corporation | 2014-12-17 | Traditional | PDF ↗ |
| K133537 | EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2014-04-28 | Special | PDF ↗ |
| K131727 | CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | 2014-02-28 | Traditional | PDF ↗ |
| K131366 | ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics Operations, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K122688 | NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR | Nova Biomedical Corporation | 2013-04-04 | Traditional | PDF ↗ |
| K121433 | GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS | Hmd Biomedical, Inc. | 2013-02-14 | Traditional | PDF ↗ |
| K122435 | NOVA ONE BLOOD GLUCOSE MONITOR | Nova Biomedical Corporation | 2012-12-20 | Traditional | PDF ↗ |
| K113314 | PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | Hmd Biomedical, Inc. | 2012-11-09 | Traditional | PDF ↗ |
| K121224 | GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2012-09-19 | Special | PDF ↗ |
| K113307 | GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM | Hmd Biomedical, Inc. | 2012-07-27 | Traditional | PDF ↗ |
| K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | Bayer Healthcare, LLC | 2012-07-26 | Special | PDF ↗ |
| K120042 | TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2012-05-22 | Special | PDF ↗ |
| K121207 | EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2012-05-18 | Special | PDF ↗ |
| K113768 | U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2012-04-12 | Special | PDF ↗ |
| K110894 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER | Bayer Healthcare | 2012-03-28 | Traditional | PDF ↗ |
| K113243 | EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2012-03-28 | Traditional | PDF ↗ |
| K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) | Bayer Healthcare, LLC | 2012-03-28 | Traditional | PDF ↗ |
| K111268 | CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM | Bayer Healthcare | 2012-03-06 | Traditional | PDF ↗ |
| K111874 | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS | Abbott Laboratories | 2012-02-16 | Traditional | PDF ↗ |
| K112901 | EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2011-12-23 | Special | PDF ↗ |
| K101299 | ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics | 2011-09-21 | Traditional | PDF ↗ |
| K110637 | ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM | Cilag GmbH International | 2011-09-07 | Traditional | PDF ↗ |
| K112272 | EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2011-09-07 | Special | PDF ↗ |
| K092688 | FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2011-07-06 | Traditional | PDF ↗ |
| K101037 | EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 | Eps Bio Technology Corp. | 2011-05-23 | Traditional | PDF ↗ |
| K083223 | RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 | Abbott Diabetes Care, Inc. | 2009-04-16 | Special | PDF ↗ |
| K070984 | THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS | Abbott Diabetes Care, Inc. | 2007-11-01 | Traditional | PDF ↗ |
| K060765 | HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 | Hemocue AB | 2006-09-06 | Traditional | PDF ↗ |
| K051592 | MODIFICATION TO ACCU-CHEK GO SYSTEM | Roche Diagnostics Corp. | 2005-09-02 | Traditional | PDF ↗ |
| K050872 | ACCU-CHEK INTEGRA SYSTEM | Roche Diagnostics Corp. | 2005-05-02 | Special | PDF ↗ |
| K043474 | ACCU-CHEK AVIVA SYSTEM | Roche Diagnostics Corp. | 2005-04-27 | Traditional | PDF ↗ |
| K041230 | CLINICAL LABORATORY ANALYZING SYSTEM | Hemocue, Inc. | 2004-05-20 | Special | PDF ↗ |
| K040796 | ACCU-CHEK GO SYSTEM | Roche Diagnostics Corp. | 2004-04-22 | Special | PDF ↗ |
| K032076 | SENOVA(R) BLOOD GLUCOSE MONITOR | Chdiagnostics, LLC | 2003-09-30 | Traditional | PDF ↗ |
| K031755 | ACCU-CHEK COMPACT TEST STRIP | Roche Diagnostics Corp. | 2003-07-03 | Special | PDF ↗ |
| K022941 | MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING | Abbott Laboratories | 2002-10-28 | Traditional | PDF ↗ |
| K021960 | PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY | Abbott Laboratories | 2002-08-16 | Traditional | PDF ↗ |
| K004010 | ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS | Roche Diagnostics Corp. | 2001-04-26 | Traditional | PDF ↗ |
| K003846 | ACCU-CHEK INFORM METER | Roche Diagnostics Corp. | 2001-03-19 | Traditional | PDF ↗ |
| K010362 | ACCU-CHEK COMFORT CURVE TEST STRIP | Roche Diagnostics Corp. | 2001-03-07 | Special | PDF ↗ |
| K000582 | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 | Abbott Diabetes Care, Inc. | 2000-12-05 | Traditional | PDF ↗ |
| K001993 | SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS | Abbott Laboratories | 2000-11-13 | Traditional | PDF ↗ |
| K994433 | CONNECT DATA MANAGEMENT SYSTEM | Abbott Diabetes Care, Inc. | 2000-05-05 | Traditional | PDF ↗ |
| K000364 | ACCU-CHEK COMPLETE METER | Roche Diagnostics Corp. | 2000-02-23 | Special | PDF ↗ |
| K992684 | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K993829 | ACCU-CHEK SIMPLICITY SYSTEM | Roche Diagnostics Corp. | 1999-12-09 | Special | PDF ↗ |
| K983047 | ACCU-CHEK HQ SYSTEM | Boehringer Mannheim Corp. | 1999-02-05 | Traditional | PDF ↗ |
| K982089 | ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS | Boehringer Mannheim Corp. | 1998-09-03 | Traditional | PDF ↗ |
| K982002 | ACCU-CHEK COMFORT CURVE TEST STRIP | Boehringer Mannheim Corp. | 1998-09-02 | Traditional | PDF ↗ |
| K982079 | ACCU-CHECK VOICEMATE | Boehringer Mannheim Corp. | 1998-08-28 | Traditional | PDF ↗ |
| K980731 | ACCU-CHEK COMFORT CURVE TEST STRIPS | Boehringer Mannheim Corp. | 1998-05-22 | Traditional | PDF ↗ |
| K973662 | ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS | Boehringer Mannheim Corp. | 1997-12-15 | Traditional | PDF ↗ |
| K972876 | GLUCOTREND BASIC SYSTEM | Boehringer Mannheim Corp. | 1997-10-09 | Traditional | PDF ↗ |
| K962415 | HEMOCUE B-GLCOSE SYSTEM | Hemocue, Inc. | 1996-10-15 | Traditional | PDF ↗ |
| K961311 | HEMOCUE B-GLUCOSE SYSTEM | Hemocue, Inc. | 1996-08-23 | Traditional | PDF ↗ |
| K954833 | ACCU-CHEK ADVANTAGE TEST STRIPS | Boehringer Mannheim Corp. | 1996-02-15 | Traditional | PDF ↗ |
| K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 | Emd Chemicals, Inc. | 1995-09-06 | Traditional | PDF ↗ |
| K951887 | ADVANTAGE TEST STRIPS | Boehringer Mannheim Corp. | 1995-08-24 | Traditional | PDF ↗ |
| K870708 | GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM | Kyoto Daiichi Kagaku Co., Ltd. | 1988-02-02 | Traditional | PDF ↗ |
| K874708 | EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 | Em Diagnostic Systems, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K860726 | ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID | Trace Scientific , Ltd. | 1986-04-21 | Traditional | PDF ↗ |
| K855080 | EMDS GLUCOSE TEST PACK ITEM 67656/95 | Em Diagnostic Systems, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K821867 | ULTRACHEM GLUC-DH | Harleco Diagnostics | 1982-07-06 | Traditional | PDF ↗ |
| K821469 | ULTRACHEM GLUC-DH, #65048 | Emd Chemicals, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K821463 | ULTRACHEM GLUC-DH, #65048 | Emd Chemicals, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K813427 | ULTRACHEM GLUC-DH | Harleco | 1981-12-31 | Traditional | PDF ↗ |
| K813042 | ULTRACHEM GLUC-DH SET, ITEM #65048 | Harleco | 1981-11-10 | Traditional | PDF ↗ |
| K811202 | ULTRACHEM GLUC-DH, ITEM NO. 65048 | Harleco | 1981-05-27 | Traditional | PDF ↗ |
| K791213 | GLUCOSE (GDH) REAGENT | Gilford Diagnostics | 1979-08-10 | Traditional | PDF ↗ |
| K791110 | KINETIC DETERMINATION OF UV GLUCOSE | The Dow Chemical Co. | 1979-08-03 | Traditional | PDF ↗ |
| K781783 | BLOOD SUGAR | Gilford Diagnostics | 1978-12-04 | Traditional | PDF ↗ |
| K771102 | UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS | The Dow Chemical Co. | 1977-11-22 | Traditional | PDF ↗ |
Product code LFR · Class II · Clinical Chemistry. Data: openFDA.