FDA 510(k) Applications for Medical Device:
Glucose Oxidase, Glucose
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K103195 | ABBOTT POINT OF CARE INC. |
400 COLLEGE RD EAST | PRINCETON | NJ | 08540 |
| K223710 | Abbott Point of Care Inc. |
400 College Road East | Princeton | NJ | 08540 |
| K210958 | Abbott Point of Care Inc. |
400 College Road East | Princeton | NJ | 08540 |
| K223755 | Abbott Point of Care Inc. |
400 College Road Test | Princeton | NJ | 08540 |
| K163271 | Abbott Point of Care, Inc. |
400 College Road East | Princeton | NJ | 08540 |
| K183678 | Abbott point of Care, Inc. |
400 College Road East | Princeton | NJ | 08540 |
| K122110 | ACON LABORATORIES, INC. |
10125 MESA RIM ROAD | SAN DIEGO | CA | 92121 |
| K111371 | ACON LABORATORIES, INC. |
10125 MESA RIM RD. | SAN DIEGO | CA | 92121 |
| K960337 | ADVANCED MEDICAL DEVICES, INC. |
152 WEST WISCONSIN AVE. | MILWAUKEE | WI | 53203 |
| K120615 | ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN |
9975 SUMMERS RIDGE RD | SAN DIEGO | CA | 92121 |
| K223179 | Alere San Diego, Inc. |
9975 Summers Ridge Rd | San Diego | CA | 92121 |
| K082965 | ALLIANCE INTERNATIONAL CO., LTD. |
NO.58, FU-CHIUN ST. | HSIN CHU CITY | 30067 | |
| K043512 | AMERICAN HEALTHCARE INC. |
304 PARK AVENUE SOUTH | NEW YORK | NY | 10010-4301 |
| K982076 | AMIRA MEDICAL, INC. |
4742 SCOTTS VALLEY DR. | SCOTTS VALLEY | CA | 95066 |
| K010605 | AMIRA MEDICAL, INC. |
4742 SCOTTS VALLEY DR. | SCOTTS VALLEY | CA | 95066 |
| K143750 | APEX BIO TECHNOLOGY CORP |
NO. 7, LI-HSIN ROAD V | HSINCHU | 30078 | |
| K131750 | APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, | HSINCHU | 30078 | |
| K090043 | APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, | HSINCHU | 30078 | |
| K102037 | APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, | HSINCHU | 30078 | |
| K113208 | APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, | HSINCHU | 30078 | |
| K113547 | APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, | HSINCHU | 30078 | |
| K142689 | Apex BioTechnology Corp. |
No. 7, Li-Hsin Road V, Hsinchu Science Park | Hsinchu | 30078 | |
| K062799 | APEX BIOTECHNOLOGY CORP. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K002624 | APEX BIOTECHNOLOGY CORP. |
3600 HOLLY LN. N. | PLYMOUTH | MN | 55447 |
| K002621 | APEX BIOTECHNOLOGY CORP. |
3600 HOLLY LN. N. | PLYMOUTH | MN | 55447 |
| K073648 | APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, | HSINCHU | 30078 | |
| K101204 | APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, | HSINCHU | 30078 | |
| K120448 | APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, | HSINCHU | 30078 | |
| K011233 | APEX BIOTECHNOLOGY CORP. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K124021 | ARKRAY FACTORY INC. |
5198 WEST 76TH ST | EDINA | MN | 55439 |
| K142336 | ARKRAY FACTORY INC. |
1480 KOJI KONAN-CHO | KOKA-SHI | 520-3306 | |
| K073416 | ARKRAY Factory USA, Inc. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K091102 | ARKRAY Factory USA, Inc. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K092104 | ARKRAY Factory USA, Inc. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K082417 | ARKRAY Factory USA, Inc. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K041427 | ARKRAY, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K972733 | AVL SCIENTIFIC CORP. |
33 MANSELL COURT | ROSWELL | GA | 30076-4807 |
| K993837 | AVL SCIENTIFIC CORP. |
235 HEMBREE PARK DR. | ROSWELL | GA | 30076 |
| K024062 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46515-0070 |
| K963500 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46514 |
| K964630 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46514-0070 |
| K991242 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46514 |
| K984006 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46514 |
| K990649 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46514 |
| K042015 | BAYER HEALTHCARE, DIAGNOSTICS DIVISION |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K103842 | BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD | BREA | CA | 92821 |
| K041478 | BECTON DICKINSON |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1880 |
| K022580 | BECTON DICKINSON & CO. |
1 BECTON DR. | FRANKLIN LAKES | NJ | 07417-1885 |
| K103116 | BESTGEN BIOTECH CORP. |
7F, NO 186, JIAN-YI ROAD | JUNG-HE, TAIPEI COUNTY | 235 | |
| K103230 | BESTGEN BIOTECH CORP. |
7F, NO 186, JIAN-YI ROAD | JUNG-HE, TAIPEI COUNTY | 235 | |
| K033627 | BIOMEDIX, INC. |
40471 ENCYCLOPEDIA CIRCLE | FREMONT | CA | 94538 |
| K050182 | BIOMEDIX, INC. |
40471 ENCYCLOPEDIA CIRCLE | FREMONT | CA | 94538 |
| K944459 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K102316 | BROADMASTER BIOTECH CORPORATION |
7F, NO. 168-2, LIANCHENG | ZHONGHE CITY | 23553 | |
| K061528 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST., SCIENCE PARK | REHOVOT | 76100 | |
| K021781 | CHAY MEDICAL, LLC. |
3257 ROUTE 128 | CALISTOGA | CA | 94515 |
| K013342 | CHAY MEDICAL, LLC. |
3257 ROUTE 128 | CALISTOGA | CA | 94515 |
| K943503 | CHEM-ELEC, INC. |
P.O. BOX 372 | NORTH WEBSTER | IN | 46555 |
| K980573 | CHRONIMED, INC. |
6214 BURY DR. | EDEN PRAIRIE | MN | 55346 |
| K963544 | CHRONIMED, INC. |
6214 BURY DR. | EDEN PRAIRIE | MN | 55346 |
| K951457 | CLINICAL DIAGNOSTICS, INC. |
132 MAIN STREET, SUITE A | CHESTER | SC | 29706 |
| K971653 | CLINICAL DIAGNOSTICS, INC. |
609 COLUMBIA RD. | CHESTER | SC | 29706 |
| K003257 | CYBERCARE TECHNOLOGIES, INC. |
7840 ROSWELL RD., BLDG. 300 | ATLANTA | GA | 30350-4889 |
| K983344 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K033055 | DIAMOND DIAGNOSTICS, INC. |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K101741 | DIATRON GROUP |
2545 MONTCLAIRE CIRCLE | WESTO | FL | 33327 |
| K070704 | DREW SCIENTIFIC, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K133584 | EOSHEALTH, INC. |
816 CONGRESS AVE, STE 1400 | AUSTIN | TX | 78701 |
| K090109 | EPOCAL, INC. |
2060 WALKLEY RD. | OTTAWA, ONTARIO | K1G-3P5 | |
| K082121 | EPS BIO TECHNOLOGY CORP. |
2 F,NO. 49-2, LANE 2, SEC. 2, | HSINCHU CITY | 30071 | |
| K061992 | EPS BIO TECHNOLOGY CORP. |
2 F,NO. 49-2, LANE 2, SEC. 2, | HSINCHU CITY | 300 | |
| K111728 | EPS BIO TECHNOLOGY CORP. |
NO.8 R&D RD III | HSINCHU CITY, HSINCHU | 30077 | |
| K043245 | EPS BIO TECHNOLOGY CORP. |
3892 SOUTH AMERICA WEST TRAIL | FLAGSTAFF | AZ | 86001 |
| K062892 | EUMED BIOTECHNOLOGY CO., LTD. |
NO. 58, FU-CHIUN ST. | HSIN CHU CITY | 300 | |
| K981183 | EXIGENT DIAGNOSTICS, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K955107 | FIREHOUSE MEDICAL, INC. |
310 WEST ORANGETHORPE AVE. | PLACENTIA | CA | 92670 |
| K121706 | FORA CARE INC. |
6F, NO. 127, WUGONG 2ND | NEW TAIPEI CITY | 24888 | |
| K971145 | GDS TECHNOLOGY, LLC. |
25235 LEER DR. | ELKHART | IN | 46514 |
| K040974 | GENCHEM, INC. |
471 W. LAMBERT RD., SUITE 107 | BREA | CA | 92821 |
| K993128 | HEALTH HERO NETWORK, INC. |
2570 WEST EL CAMINO REAL | MOUNTAIN VIEW | CA | 94040-1309 |
| K020935 | HEMOCUE, INC. |
9229 CRANFORD DR. | POTOMAC | MD | 20854 |
| K960855 | HOME DIAGNOSTICS, INC. |
2600 N.W. 55TH COURT | FT LAUDERDALE | FL | 33309 |
| K992988 | HOME DIAGNOSTICS, INC. |
24OO N.W. 55TH CT. | FORT LAUDERDALE | FL | 33309 |
| K080636 | HUBDIC CO., LTD |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K041881 | HYPOGUARD USA, INC. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K053079 | HYPOGUARD USA, INC. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K024347 | HYPOGUARD USA, INC. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K020232 | HYPOGUARD USA, INC. |
5182 WEST 76TH ST. | EDINA | MN | 55439 |
| K031388 | HYPOGUARD USA, INC. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K103278 | i-SENS, Inc. |
465-6 WOLGYE-DONG, NOWON-GU | SEOUL | 139-845 | |
| K121654 | i-SENS, Inc. |
465-6 WOLGYE-DONG, NOWON-GU | SEOUL | 139-845 | |
| K120759 | i-SENS, Inc. |
465-6 WOLGYE-DONG, NOWON-GU | SEOUL | 139-845 | |
| K001387 | I-STAT CORP. |
104 WINDSOR CENTER DR. | EAST WINDSOR | NJ | 08520 |
| K001092 | INBIOS INTL., INC. |
562 1ST. AVE. SOUTH, SUITE 600 | SEATTLE | WA | 98104 |
| K052207 | INCLINE MEDICAL, LLC |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K113670 | INFOPIA CO., LTD |
951 STARBUCK ST. UNIT J | FULLERTON | CA | 92833 |
| K051285 | INFOPIA CO., LTD |
889-3, KWANYANG2-DONG, | ANYANG KVUNGGI | 431-716 | |
| K153692 | INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) |
17408 TILLER COURT SUITE 1900 | WESTFIELD | IN | 40674 |
| K223090 | Instrumentation Laboratory Co |
180 Hartwell Road | Bedford | MA | 01730 |
| K052121 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K161818 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K010520 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K160402 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K183546 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K022158 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K091975 | INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K011479 | INVERNESS MEDICAL INNOVATIONS, INC. |
51 SAWYER RD., SUITE 200 | WALTHAM | MA | 02453-3448 |
| K955286 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14650-0882 |
| K984527 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K031472 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K974451 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K972473 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K021943 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K043197 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K001441 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K984261 | LIFESCAN, INC. |
700 THIRTEENTH ST. NW | WASHINGTON | DC | 20005 |
| K970556 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K023194 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K973140 | LXN CORP. |
5830 OBERLIN DR. | SAN DIEGO | CA | 92121 |
| K990942 | LXN CORP. |
6325 LUSK BLVD. | SAN DIEGO | CA | 92121 |
| K991754 | LXN CORP. |
6325 LUSK BLVD. | SAN DIEGO | CA | 92121 |
| K960034 | LXN CORP. |
5830 OBERLIN DR. | SAN DIEGO | CA | 92121 |
| K002688 | LXN CORP. |
6325 LUSK BLVD. | SAN DIEGO | CA | 92121 |
| K070057 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K100187 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K961337 | MEDISENSE, INC. |
266 SECOND AVE. | WALTHAM | MA | 02154 |
| K963676 | MEDISENSE, INC. |
4A CROSBY DR. | BEDFORD | MA | 01730 |
| K982303 | MEDISENSE, INC. |
4-A CROSBY DR. | BEDFORD | MA | 01730-1402 |
| K962295 | MEDISENSE, INC. |
266 SECOND AVE. | WALTHAM | MA | 02154 |
| K971812 | MEDISENSE, INC. |
4A CROSBY DR. | BEDFORD | MA | 01730 |
| K983504 | MEDISENSE, INC. |
4-A CROSBY DR. | BEDFORD | MA | 01730-1402 |
| K063821 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K060345 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K070960 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K203549 | Nova Biomedical Corporation |
200 Prospect Street | Waltham | ME | 02454 |
| K180340 | Nova Biomedical Corporation |
200 Prospect St. | Waltham | MA | 02454 |
| K200349 | Nova Biomedical Corporation |
200 Prospect Street | Waltham | MA | 02454 |
| K163433 | Ortho Clinical Diagnostics |
100 Indigo Creek Drive | Rochester | NY | 14626 |
| K190520 | Ortho-Clinical Diagnostics, Inc. |
100 Indigo Creek Drive | Rochester | NY | 14626 |
| K113636 | PHILOSYS CO. LTD. |
304 PARK AVENUE SOUTH | NEW YORK | NY | 10010 |
| K970781 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K013068 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K142302 | Polymer Technology Systems, Inc. |
7736 Zionsville Rd. | Indianapolis | IN | 46268 |
| K151530 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 Zionsville Rd | INDIANAPOLIS | IN | 46268 |
| K972669 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K162282 | Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
7736 Zionsville Road | Indianapolis | IN | 46268 |
| K182781 | Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
7736 Zionsville Road | Indianapolis | IN | 46268 |
| K003346 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K024014 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K000365 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K001907 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K014139 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K961985 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K970707 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K991480 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K000583 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K990939 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K993632 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K001427 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K002134 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K960053 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K151639 | SENDX MEDICAL INC |
1945 PALOMAR OAKS WAY | CARLSBAD | CA | 92011 |
| K100525 | SEPPIM S.A.S. |
21720 23RD DR SE | BOTHELL | WA | 98021 |
| K963535 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K120921 | SIMPLE DIAGNOSTICS, INC. |
8870 RAVELLO CT | NAPLES | FL | 34114 |
| K101947 | SPHERE MEDICAL LTD. |
HARSTON MILL, HARSTON | CAMBRIDGE | CM22 7GG | |
| K081609 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 248 | |
| K093506 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 24888 | |
| K093941 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 248 | |
| K091814 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 24888 | |
| K100405 | TaiDoc Technology Corporation |
3F,5F, NO.127 WUGONG 2ND RD. | TAIPEI COUNTY | 24888 | |
| K081714 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 248 | |
| K083664 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 241 | |
| K082482 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 241 | |
| K100406 | TaiDoc Technology Corporation |
3F,5F, NO.127 WUGONG 2ND RD. | TAIPEI COUNTY | 24888 | |
| K083570 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 241 | |
| K061431 | US DIAGNOSTICS, INC. |
304 PARK AVENUE SOUTH | NEW YORK | NY | 10010-4301 |
| K011953 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
