FDA 510(k) Applications for Medical Device:
Method, Nephelometric, Immunoglobulins (G, A, M)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K162208 | BECKMAN COULTER INC. |
250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 | BREA | CA | 92821 |
| K221114 | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. |
No. 181 West Su Hong Road, Suzhou Industrial Park | Suzhou | 215021 | |
| K130122 | BECKMAN COULTER, INC |
250 S. KRAEMER BLVD | BREA | CA | 92821 |
| K993549 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K993547 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K061338 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K061845 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K081161 | DADE BEHRING, INC. |
500 GBC DR, MAILSTOP 514 | NEWARK | DE | 19714-6101 |
| K073561 | DADE BEHRING, INC. |
P.O BOX 6101, MS514 | NEWARK | DE | 19714-6101 |
| K042735 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K032014 | DADE BEHRING, INC. |
GLASGOW SITE | NEWARK | DE | 19714-6101 |
| K073489 | OLYMPUS AMERICA INC. |
LISMEEHAN, O, CALLAGHAN'S | CO. CLARE | ||
| K073490 | OLYMPUS AMERICA INC. |
LISMEEHAN, O, CALLAGHAN'S | CO. CLARE | ||
| K073487 | OLYMPUS AMERICA INC. |
LISMEEHAN, O, CALLAGHAN'S | CO. CLARE | ||
| K042475 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K982382 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K090594 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19714-6101 |
| K083445 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE M/S 514 | NEWARK | DE | 19714 |
| K233663 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring-Str. 76 | Marburg | 35041 | |
| K042152 | THE BINDING SITE |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K103824 | THE BINDING SITE |
PO BOX 11712 | BIRMINGHAM | B14 4ZB | |
| K082823 | THE BINDING SITE GROUP LTD |
12100 WILSHIRE BLVD | LOS ANGELES | CA | 90025-7121 |
| K113823 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD | BIRMINGHAM, WEST MIDLANDS | B15 1QT | |
| K192116 | The Binding Site Group Ltd |
8 Calthorpe Road Edgbaston | Birmingham | B15 1QT | |
| K100588 | THE BINDING SITE GROUP LTD |
12100 WILSHIRE BL., SUITE 500 | LOS ANGELES | CA | 90025 |
| K120749 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD | BIRMINGHAM, WEST MIDLANDS | B15 1QT | |
| K120750 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD | BIRMINGHAM, WEST MIDLANDS | B15 1QT | |
| K150526 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD | BIRMINGHAM, WEST MIDLANDS | B15 1QT | |
| K142735 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD, EDGBASTON | BIRMINGHAM | B15 1QT | |
| K191465 | The Binding Site Group Ltd. |
8 Calthorpe Road | Edgbaston | B15 1qt | |
| K183151 | The Binding Site Group Ltd. |
8 Calthorpe Road | Birmingham | B15 1qt | |
| K191985 | The Binding Site Group Ltd. |
8 Calthorpe Road | Edgbaston | B15 1QT | |
| K190686 | The Binding Site Group Ltd. |
8 Calthorpe Road | Edgbaston | B15 1qt | |
| K191635 | The Binding Site Group Ltd. |
8 Calthorpe Road | Edgbaston | B15 1QT | |
| K120901 | THE BINDING SITE GROUP, LTD. |
8 CALTHORPE ROAD | EDGBASTON | B15 1QT | |
| K081827 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K981912 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K022083 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K000701 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K090920 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K072889 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K012296 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K012291 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K012292 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K012295 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K082129 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K982100 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K981784 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K993924 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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