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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013643 | AUSAM BIOTECTHNOLOGIES INC |
50 ROCKEFELLER PLAZA | NEW YORK | NY | 10020 |
| K965035 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821-6208 |
| K971458 | DIAGNOSTIC SPECIALTIES |
4 LEONARD ST. | METUCHEN | NJ | 08840-4338 |
| K991800 | OSBORN GROUP, INC. |
14901 WEST 117TH ST. | OLATHE | KS | 66062 |
| K141925 | Roche Diagnostics Operations (RDO) |
9115 Hague Road | Indianapolis | IN | 46250 |