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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 |
|---|---|---|---|---|---|
| K052549 | ESA BIOSCIENCES INC. |
22 ALPHA RD. | CHELMSFORD | MA | 01824-4171 |
| K971640 | ESA, INC. |
22 ALPHA RD. | CHELMSFORD | MA | 01824-4171 |
| K123563 | MAGELLAN DIAGNOSTICS |
101 BILLERICA AVE. | NORTH BILLERICA | MA | 01862-1271 |
| K142705 | Magellan Diagnostics |
101 Billerica Ave. Bldg #4 | North Billerica | MA | 01862 |