FDA 510(k) Applications for Medical Device:
Automated Urinalysis System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K070929 | ACON LABORATORIES, INC. |
4139 GARDENDALE CENTER, #101 | SAN ANTONIO | TX | 78229 |
| K142543 | ACON LABORATORIES, INC. |
10125 MESA RIM ROAD | SAN DIEGO | CA | 92121 |
| K091472 | ARJ MEDICAL, INC. |
209 STATE STREET | OLDSMAR | FL | 34677 |
| K121456 | ARKRAY, INC. |
5182 West 76th Street | Edina | MN | 55439 |
| K093098 | ARKRAY, INC. |
1201 RICHARDSON DRIVE | RICHARDSON | TX | 75080 |
| K960546 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46514-0070 |
| K031947 | BAYER HEALTHCARE, LLC |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K012829 | BIOCARE CORP. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K983510 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K951877 | CHIMERA RESEARCH & CHEMICAL, INC. |
P.O. BOX 3363 | SEMINOLE | FL | 33775 |
| K102188 | DFI CO., LTD. |
#821 SAMIL PLAZA, 837-26 | GANGNAM-GU, SEOUL | 135-937 | |
| K053253 | HEMOCUE AB |
40 EMPIRE DRIVE | LAKE FOREST | CA | 92630 |
| K030600 | INTERNATIONAL REMOTE IMAGING SYSTEMS |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K013783 | INTERNATIONAL REMOTE IMAGING SYSTEMS |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K960054 | INTL. REMOTE IMAGING SYSTEMS |
9162 ETON AVE. | CHATSWORTH | CA | 91311 |
| K972141 | INTL. REMOTE IMAGING SYSTEMS |
9162 ETON AVE. | CHATSWORTH | CA | 91311 |
| K101852 | IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I |
9172 ETON AVENUE | CHATSWORTH | CA | 91311 |
| K093555 | Roche Diagnostics |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K954514 | Sciteck Diagnostics, Inc. |
P.O. BOX 562 | Arden | NC | 28704 |
| K140717 | SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE | NORWOOD | MA | 02062 |
| K954158 | SOLARCARE TECHNOLOGIES CORP,INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K954156 | SOLARCARE TECHNOLOGIES CORP,INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K042421 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K051526 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K141874 | YD DIAGNOSTICS CORP. |
#821 SAMIL PLAZA | GANGNAM-GU, SEOUL | 135-768 | |
| K980047 | YEONGDONG PHARMACEUTICAL CORP. |
55 NORTHERN BLVD, SUITE 410 | GREAT NECK | NY | 11021 |
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