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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 |
|---|---|---|---|---|---|
| K955448 | BEHRING DIAGNOSTICS, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K955814 | MICROGENICS CORP. |
2380 A BISSO LN. | CONCORD | CA | 94520 |
| K961436 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |