FDA 510(k) Applications for Medical Device:
System, Test, Beta-2-Microglobulin Immunological
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K993711 |
BAYER CORP. |
511 BENEDICT AVE.
| TARRYTOWN |
NY |
10591-5097 |
K964791 |
BAYER CORP. |
511 BENEDICT AVE.
| TARRYTOWN |
NY |
10591-5097 |
K161297 |
Beckman Coulter Ireland Inc. |
Lismeehan, O'Callaghan's Mills
| Co. Clare |
|
|
K983895 |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110
| BREA |
CA |
92822 |
K973813 |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD.
| BREA |
CA |
92821-6208 |
K955596 |
BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE.
| WESTWOOD |
MA |
02090 |
K001022 |
BIOCHECK, INC. |
9418 LASAINE AVE.
| NORTHRIDGE |
CA |
91325 |
K050613 |
BIOKIT S.A. |
LLISSA D'AMUNT
| BARCELONA |
|
08186 |
K072078 |
BIOKIT S.A. |
CAN MALE S/N
| BARCELONA |
|
08186 |
K980724 |
BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR.
| PLEASANTON |
CA |
94588-2722 |
K063272 |
DADE BEHRING, INC. |
P.O. BOX 6101
| NEWARK, |
DE |
19714 |
K002731 |
DADE BEHRING, INC. |
7739 NW 48 ST.
| MIAMI |
FL |
33166 |
K032692 |
DAKO A/S |
2128 W EVERGREEN AVE.
| CHICAGO |
IL |
60622 |
K991136 |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR.
| MELVILLE |
NY |
11747-3157 |
K964767 |
R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E.
| MINNEAPOLIS |
MN |
55413 |
K083463 |
SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE
| NEWARK |
DE |
19714-6101 |
K110874 |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE
| TARRYTOWN |
NY |
10591 |
K122066 |
THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD
| BIRMINGHAM, WEST MIDLANDS |
|
B15 1QT |
K946069 |
THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600
| SANTA MONICA |
CA |
90404 |
K946068 |
THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600
| SANTA MONICA |
CA |
90404 |
K083289 |
THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000
| SANTA MONICA |
CA |
90404 |
K946070 |
THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600
| SANTA MONICA |
CA |
90404 |
K014270 |
THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000
| SANTA MONICA |
CA |
90404 |
|
|