FDA 510(k) Applications for Medical Device:
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K120124 | ACON LABORATORIES, INC. |
10125 MESA RIM ROAD | SAN DIEGO | CA | 92121 |
| K973142 | AMERITEK, INC. |
7030 35TH AVE., N.E. | SEATTLE | WA | 98115 |
| K061812 | ANALYTICON BIOTECHNOLOGIES AG |
AM MUEHLENBERG 10 | LICHTENFELS | 35104 | |
| K061846 | ANALYTICON BIOTECHNOLOGIES AG |
AM MUEHLENBERG 10 | LICHTENFELS, HESSEN | 35104 | |
| K023885 | ANALYTICON BIOTECHNOLOGIES AG |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K193514 | Arkray Inc. |
Yousuien-Nai, 59 Gansuin-Cho | Kamigyo-ku | 602-0008 | |
| K160062 | ARKRAY, Inc. |
Yousuien-Nai, 59 Gansuin-Cho | Kamigyo-Ku | 602-0008 | |
| K022386 | ARKRAY, INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K063276 | BAYER HEALTHCARE, LLC |
2 EDGEWATER DR. | NORWOOD | MA | 02062-4658 |
| K042641 | CENOGENICS CORP. |
100 RT. 520 | MORGANVILLE | NJ | 07751 |
| K052525 | D.F.I. CO LTD |
2815 MCGAW AVENUE | IRVINE | CA | 92614 |
| K181024 | DFI Co., Ltd. |
388-25, Gomo-ro, Jillye-myeon, Gimhae-si | Gyeongsangnam-do | 621-881 | |
| K171521 | DFI Co., Ltd. |
388-25, Gomo-ro, Jillye-myeon, Gimhae-si | Gyeongsangnam-do | 621-881 | |
| K961375 | GENESIS LABS, INC. |
5183 W. 76TH ST. | MINNEAPOLIS | MN | 55435 |
| K173327 | Healthy.io Ltd |
27 Rothschild Boulevard | Tel Aviv | 6688206 | |
| K010973 | HYPOGUARD USA, INC. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K033851 | HYPOGUARD USA, INC. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K063390 | IND DIAGNOSTIC INC. |
P.O. BOX 162 | ALTAMONTE SPRINGS | FL | 32716 |
| K171083 | Iris Diagnostics, a Division of Iris International Inc |
9172 Eton Avenue | Chatsworth | CA | 91311 |
| K060280 | IRIS INTERNATIONAL, INC. |
9172 ETON AVE. | CHATSWORTH | CA | 91311 |
| K051034 | MACHEREY-NAGEL GMBH & CO., KG. |
7361 CALHOUN PLACE, SUITE 500 | ROCKVILLE | MD | 20855 |
| K061742 | MACHEREY-NAGEL GMBH & CO., KG. |
7361 CALHOUN PLACE, SUITE 500 | ROCKVILLE | MD | 20855 |
| K991927 | MACHEREY-NAGEL-DUREN |
7475 WISCONSIN ANE | BETHESDA | MD | 20814 |
| K953661 | POLYMER TECHNOLOGY INTL. |
1871 N.W. GILMAN BLVD. | ISSAQUAH | WA | 98027 |
| K183432 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K032437 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K012397 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K180356 | Scanadu, Inc. |
1196 Borregas Ave., Ste 200 | Sunnyvale | CA | 94089 |
| K091216 | SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE | NORWOOD | MA | 02062 |
| K954968 | TCPI, INC. |
15 OAK ST. | BEVERLY FARMS | MA | 01915 |
| K970250 | TECO DIAGNOSTICS |
4925 EAST HUNTER AVE. | ANAHEIM | CA | 92807 |
| K141289 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K101673 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K131600 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K020175 | TECO DIAGNOSTICS |
1268 . LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K160372 | TECO DIAGNOSTICS, INC. |
1268 N. LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K050801 | YD DIAGNOSTICS |
707 FOOTHILL BLVD. STE. 200 | LA CANADA | CA | 91011 |
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