FDA Product Code
FDA Product Code NBW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 511 records · page 4 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093764 | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM | Biotest Medical Corp. | 2010-03-02 | Special | PDF ↗ |
| K093592 | ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 | Taidoc Technology Corporation | 2010-02-25 | Special | PDF ↗ |
| K092894 | EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2010-02-24 | Special | PDF ↗ |
| K093475 | BASESENS BLOOD GLUCOSE MONITORING SYSTEM | Hygeia, Inc. | 2010-02-24 | Traditional | PDF ↗ |
| K093789 | INTOUCH DIABETES | Symcare Personalized Health Solutions, Inc. | 2010-02-19 | Traditional | PDF ↗ |
| K093712 | FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2010-02-19 | Special | PDF ↗ |
| K093635 | MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS | Taidoc Technology Corporation | 2010-02-18 | Special | PDF ↗ |
| K093005 | FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 | Taidoc Technology Corporation | 2010-02-05 | Special | PDF ↗ |
| K090609 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | 2010-02-04 | Traditional | PDF ↗ |
| K091765 | EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM | Visgeneer, Inc. | 2010-01-19 | Traditional | PDF ↗ |
| K091547 | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS | Nova Biomedical Corp. | 2010-01-15 | Traditional | PDF ↗ |
| K093035 | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 | Taidoc Technology Corporation | 2009-12-24 | Special | PDF ↗ |
| K092099 | NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 | Taidoc Technology Corporation | 2009-12-10 | Special | PDF ↗ |
| K082683 | SD CHECK GOLD | Standard Diagnostics, Inc. | 2009-12-08 | Traditional | PDF ↗ |
| K090628 | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 | Bayer Healthcare, LLC | 2009-12-04 | Traditional | PDF ↗ |
| K090405 | LIPIDPRO SYSTEM | Infopia Co, Ltd. | 2009-12-01 | Traditional | PDF ↗ |
| K083273 | MICRODOT XTRA | Cambridge Sensors Limited | 2009-11-19 | Traditional | PDF ↗ |
| K091157 | GLUCO LAB AUTO CODING, MODEL IGM-0022 | Infopia Co, Ltd. | 2009-11-17 | Special | PDF ↗ |
| K091815 | SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 | Biotest Medical Corp. | 2009-11-16 | Traditional | PDF ↗ |
| K092887 | EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 | Eps Bio Technology Corp. | 2009-10-21 | Special | PDF ↗ |
| K090653 | POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory USA, Inc. | 2009-10-09 | Traditional | PDF ↗ |
| K090712 | EOCENE SYSTEM | Infopia Co, Ltd. | 2009-10-02 | Special | PDF ↗ |
| K091898 | BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 | Taidoc Technology Corporation | 2009-09-18 | Special | PDF ↗ |
| K091820 | CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM | Bayer Healthcare | 2009-08-26 | Special | PDF ↗ |
| K091481 | EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | 2009-08-18 | Special | PDF ↗ |
| K090332 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 | Arkray Factory USA, Inc. | 2009-08-14 | Traditional | PDF ↗ |
| K091229 | GLUCOMANAGER DATA MANAGEMENT SOFTWARE | Eps Bio Technology Corp. | 2009-07-31 | Traditional | PDF ↗ |
| K091296 | POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 | Polymap Wireless | 2009-07-17 | Abbreviated | PDF ↗ |
| K090389 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM | Bestgen Biotech Corp. | 2009-07-14 | Traditional | PDF ↗ |
| K090188 | U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 | Taidoc Technology Corporation | 2009-07-13 | Traditional | PDF ↗ |
| K090404 | FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 | Taidoc Technology Corporation | 2009-06-23 | Special | PDF ↗ |
| K090629 | EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS | Tyson Bioresearch, Inc. | 2009-06-04 | Special | PDF ↗ |
| K090187 | FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 | Taidoc Technology Corporation | 2009-05-12 | Traditional | PDF ↗ |
| K083628 | GLUCODR AUTO SYSTEM | All Medicus Co., Ltd. | 2009-05-01 | Traditional | PDF ↗ |
| K090185 | CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2009-04-24 | Special | PDF ↗ |
| K090057 | ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM | Acon Laboratories Co. | 2009-04-08 | Traditional | PDF ↗ |
| K090495 | TRUEBALANCE BLOOD GLUCOSE SYSTEM | Home Diagnostics, Inc. | 2009-03-27 | Special | PDF ↗ |
| K090536 | FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247 | Taidoc Technology Corporation | 2009-03-26 | Special | PDF ↗ |
| K062187 | BETACHEK GLUCOSE TEST | National Diagnostic Products | 2009-03-24 | Traditional | PDF ↗ |
| K083263 | SYMCARE DIABETES MANAGEMENT PROGRAM | Symcare Personalized Health Solutions, Inc. | 2009-03-13 | Traditional | PDF ↗ |
| K082328 | GLUCODR PLUS SYSTEM, MODEL AGM-3000 | All Medicus Co., Ltd. | 2009-02-27 | Traditional | PDF ↗ |
| K082201 | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A | U. S. Diagnostics, Inc. | 2009-02-20 | Traditional | PDF ↗ |
| K080853 | DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM | Genexel-Sein, Inc. | 2009-02-20 | Abbreviated | PDF ↗ |
| K083468 | CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) | I-Sens, Inc. | 2009-02-10 | Special | PDF ↗ |
| K083265 | JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 | Agamatrix, Inc. | 2009-02-03 | Special | PDF ↗ |
| K081796 | EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM | Eps Bio Technology Corp. | 2009-01-23 | Traditional | PDF ↗ |
| K083099 | EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 | Eps Bio Technology Corp. | 2009-01-16 | Special | PDF ↗ |
| K082521 | EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM | Card Guard Scientific Survival , Ltd. | 2009-01-16 | Traditional | PDF ↗ |
| K081703 | MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS | Entra Health Systems, Ltd. | 2009-01-08 | Traditional | PDF ↗ |
| K082020 | ENVISION BLOOD GLUCOSE TEST SYSTEM | Infopia Co, Ltd. | 2008-12-24 | Traditional | PDF ↗ |
| K081715 | FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM | Taidoc Technology Corporation | 2008-12-17 | Special | PDF ↗ |
| K082169 | PRO GLUCOSE TEST STRIP | Taidoc Technology Corporation | 2008-12-04 | Traditional | PDF ↗ |
| K081975 | RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) | Abbott Diabetes Care, Inc. | 2008-11-26 | Special | PDF ↗ |
| K082513 | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2008-10-22 | Special | PDF ↗ |
| K080923 | CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB | I-Sens, Inc. | 2008-10-17 | Traditional | PDF ↗ |
| K082486 | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE | Bayer Healthcare, LLC | 2008-10-08 | Special | PDF ↗ |
| K082618 | ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 | Taidoc Technology Corporation | 2008-10-07 | Special | PDF ↗ |
| K081451 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 | Bionime Corporation | 2008-09-18 | Special | PDF ↗ |
| K081450 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 | Bionime Corporation | 2008-09-11 | Special | PDF ↗ |
| K080960 | PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS | Abbott Diabetes Care, Inc. | 2008-09-05 | Traditional | PDF ↗ |
| K081726 | TYSONBIO LINK HEALTH MANAGEMENT SYSTEM | Tyson Bioresearch, Inc. | 2008-08-26 | Traditional | PDF ↗ |
| K080641 | TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 | Home Diagnostics, Inc. | 2008-08-19 | Traditional | PDF ↗ |
| K080710 | TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 | Home Diagnostics, Inc. | 2008-08-13 | Traditional | PDF ↗ |
| K081957 | U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2008-08-05 | Special | PDF ↗ |
| K073030 | AG-605 BLOOD GLUCOSE MONITORING SYSTEM | Andon Health Co, Ltd. | 2008-07-21 | Traditional | PDF ↗ |
| K081389 | ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics | 2008-07-15 | Special | PDF ↗ |
| K080538 | IDEAL LIFE POD (MODEL ILP 0001) | Ideal Life, Inc. | 2008-07-03 | Traditional | PDF ↗ |
| K072854 | DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM | Tyson Bioresearch, Inc. | 2008-06-30 | Traditional | PDF ↗ |
| K080283 | IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2008-06-27 | Traditional | PDF ↗ |
| K081144 | CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 | Taidoc Technology Corporation | 2008-06-23 | Special | PDF ↗ |
| K080014 | CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | Taidoc Technology Corporation | 2008-06-09 | Traditional | PDF ↗ |
| K081318 | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM | Lifescan, Inc. | 2008-06-09 | Special | PDF ↗ |
| K080501 | SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 | Taidoc Technology Corporation | 2008-04-21 | Special | PDF ↗ |
| K072905 | 3TEST SUPREME GLUCOSE MONITORING SYSTEM | Neuero Engineering, Inc. | 2008-04-18 | Traditional | PDF ↗ |
| K073231 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2008-04-18 | Traditional | PDF ↗ |
| K073492 | DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM | Tyson Bioresearch, Inc. | 2008-04-08 | Traditional | PDF ↗ |
| K073494 | CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING | Taidoc Technology Corporation | 2008-04-02 | Special | PDF ↗ |
| K073137 | GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 | Apex BioTechnology Corp. | 2008-04-01 | Traditional | PDF ↗ |
| K073699 | MCT-DIABETES | Mycare Team, Inc. | 2008-03-26 | Traditional | PDF ↗ |
| K072441 | EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM | Tyson Bioresearch, Inc. | 2008-03-25 | Traditional | PDF ↗ |
| K072369 | EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM | Hmd Biomedical, LLC | 2008-03-21 | Traditional | PDF ↗ |
| K073118 | PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM | Diagnostic Devices, Inc. | 2008-03-05 | Traditional | PDF ↗ |
| K073119 | CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2008-03-03 | Traditional | PDF ↗ |
| K072274 | MAJOR III BLOOD GLUCOSE MONITORING SYSTEM | Bestgen Biotech Corp. | 2008-02-29 | Traditional | PDF ↗ |
| K072054 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 | Bionime Corporation | 2008-02-28 | Traditional | PDF ↗ |
| K073573 | WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM | Agamatrix | 2008-01-30 | Special | PDF ↗ |
| K072784 | PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2007-12-21 | Traditional | PDF ↗ |
| K070053 | EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 | Eps Bio Technology Corp. | 2007-12-03 | Traditional | PDF ↗ |
| K071493 | CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 | Taidoc Technology Corporation | 2007-10-26 | Traditional | PDF ↗ |
| K072543 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2007-10-05 | Special | PDF ↗ |
| K072039 | ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F | Taidoc Technology Corporation | 2007-10-03 | Special | PDF ↗ |
| K072413 | MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM | Agamatrix | 2007-09-27 | Special | PDF ↗ |
| K072489 | REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | 2007-09-20 | Special | PDF ↗ |
| K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS | Polymer Technology Systems, Inc. | 2007-09-10 | Special | PDF ↗ |
| K063771 | GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM | Arkray Factory USA, Inc. | 2007-08-09 | Traditional | PDF ↗ |
| K071393 | JAZZ BLOOD GLUCOSE MONITORING SYSTEM | Agamatrix | 2007-07-20 | Special | PDF ↗ |
| K062377 | MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 | Medapps, Inc. | 2007-07-03 | Traditional | PDF ↗ |
| K070559 | POLYMAP PWR-08-03 | Polymap Wireless | 2007-06-29 | Abbreviated | PDF ↗ |
| K070524 | MICRODOT BLOOD GLUCOSE MONITORING SYSTEM | Cambridge Sensors Limited | 2007-06-22 | Traditional | PDF ↗ |
| K070941 | CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 | Taidoc Technology Corporation | 2007-06-21 | Traditional | PDF ↗ |
Product code NBW · Class II · Clinical Chemistry. Data: openFDA.