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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 |
|---|---|---|---|---|---|
| K233352 | Hologic, Inc. |
10210 Genetic Center Drive | San Diego | CA | 92121 |
| K221007 | Roche Molecular Systems, Inc. |
4300 Hacienda Drive | Pleasanton | CA | 94588-2722 |