FDA 510(k) Applications for Medical Device:
Complement C3, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983441 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K991907 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K032035 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K964842 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92822-8000 |
| K955857 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K964298 | CRESTAT DIAGNOSTICS, INC. |
25549 ADAMS AVE. | MURRIETA | CA | 92562 |
| K994296 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K061852 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K050665 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K032796 | IBL GMBH |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301 |
| K962199 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K993437 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K962409 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K042494 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K000469 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K012361 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K100179 | THE BINDING SITE GROUP, LTD. |
| LOS ANGELE | CA | 90025-7121 |
| K981783 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K063150 | THERMO ELECTRON OY |
RATASTIE 2 | VANTAA | FIN-01621 | |
| K010326 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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