FDA 510(k) Applications for Medical Device:
Counter, Urine Particle
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K232416 | Arkray Inc. |
Yousuien-Nai, 59 Gansuin-Cho | Kyoto | 602-0008 | |
| K210127 | Beckman Coulter, Inc. |
11800 SW 147th Ave | Miami | FL | 33196 |
| K000373 | INTL. REMOTE IMAGING SYSTEMS |
9162 ETON AVE. | CHATSWORTH | CA | 91311 |
| K022774 | INTL. REMOTE IMAGING SYSTEMS |
9162 ETON AVE. | CHATSWORTH | CA | 91311 |
| K093861 | IRIS INTERNATIONAL, INC. |
9172 ETON AVE. | CHATSWORTH | CA | 91311 |
| K200811 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46256 |
| K171883 | Sysmex America, Inc. |
577 Aptakisic Road | Lincolnshire | IL | 60069 |
| K070910 | SYSMEX AMERICA, INC. |
ONE NELSON C. WHITE PARKWAY | MUNDELEIN | IL | 60060 |
| K080887 | SYSMEX AMERICA, INC. |
ONE NELSON C. WHITE PARKWAY | MUNDELEIN | IL | 60060 |
| K053135 | SYSMEX AMERICA, INC. |
ONE NELSON C. WHITE PARKWAY | MUNDELEIN | IL | 60060 |
| K083002 | SYSMEX AMERICA, INC. |
ONE NELSON C. WHITE PARKWAY | MUNDELEIN | IL | 60060 |
| K961054 | SYSMEX CORP. |
GILMER RD. | LONG GROVE | IL | 60047-9596 |
| K012372 | SYSMEX CORP. |
GILMER RD. | LONG GROVE | IL | 60047-9596 |
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