FDA 510(k) Applications for Medical Device:
Complement C4, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983356 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K964297 | CRESTAT DIAGNOSTICS, INC. |
25549 ADAMS AVE. | MURRIETA | CA | 92562 |
| K964300 | CRESTAT DIAGNOSTICS, INC. |
25549 ADAMS AVE. | MURRIETA | CA | 92562 |
| K994293 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K962198 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K993481 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K962582 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K000468 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | ANTRIM, N. IRELAND | ||
| K012359 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K100455 | THE BINDING SITE |
12100 WILSHIRE BLVD | LOS ANGELES | CA | 90025 |
| K981785 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K010325 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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