FDA 510(k) Applications for Medical Device:
Kappa, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964260 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K153394 | Diazyme Laboratories |
12889 Gregg Court | Poway | CA | 92064 |
| K211648 | Diazyme Laboratories Inc. |
12889 Gregg Court | Poway | CA | 92064 |
| K220001 | Diazyme Laboratories Inc. |
12889 Gregg Court | Poway | CA | 92064 |
| K181438 | Diazyme Laboratories Inc. |
12889 Gregg Court | Poway | CA | 92130 |
| K210623 | Sebia |
1705 Corporate Drive Suite 400 | Norcross | GA | 30093 |
| K231601 | Sebia |
1705 Corporate Drive Suite 400 | Norcross | GA | 30093 |
| K042939 | Sebia, Inc. |
13805 WATERLOO | CHELSEA | MI | 48118 |
| K083602 | SENTINEL CH. SpA |
Via Robert Koch, 2 | Milano | 20152 | |
| K082503 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC | NEWARK | DE | 19714-6101 |
| K182098 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring-Str. 76 | Marburg | 35041 | |
| K171742 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring-Str. 76 | Marburg | 35041 | |
| K190879 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring Str-76 | Marburg | 35041 | |
| K212379 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring Str. 76 | Marburg | 35041 | |
| K193047 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring-Str. 76 | Marburg | 35041 | |
| K201496 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring-Str.- 76 | Marburg | 35041 | |
| K120056 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD | BIRMINGHAM, WEST MIDLANDS | B15 1QT | |
| K150658 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD, | BIRMINGHAM | B15 1QT | |
| K173732 | The Binding Site Group Ltd |
8 Calthorpe Road Edgbaston | Birmingham | B15 1QT | |
| K250549 | The Binding Site Group Ltd |
8 Calthorpe Road | Birmingham | B15 1QT | |
| K231290 | The Binding Site Ltd. |
8 Calthorpe Road | Birmingham | B15 1QT | |
| K023009 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K070900 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K062372 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K051915 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K040009 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K003669 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K002564 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
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