FDA 510(k) Applications for Medical Device:
Assay, Erythropoietin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K183088 | Axis-Shield Diagnostics Limited |
Luna Place, The Technology Park | Dundee | DD2 1XA | |
| K240182 | Beckman Coulter Inc |
1000 Lake Hazeltine Drive | Chaska | MN | 55318 |
| K052223 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K983203 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K954898 | GENZYME CORP. |
ONE KENDALL SQUARE | CAMBRIDGE | MA | 02139 |
| K952559 | NICHOLS INSTITUTE |
33608 ORTEGA HIGHWAY | SAN JUAN CAPISTRANO | CA | 92690 |
| K980737 | NICHOLS INSTITUTE DIAGNOSTICS |
33051 CALLE AVIADOR | SAN JUAN CAPISTRANO | CA | 92675 |
| K992799 | SANGUI BIOTECH, INC. |
1508 BROOKHOLLOW DR., #354 | SANTA ANA | CA | 92705 |
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