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 |
K954514 |
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 |
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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