FDA 510(k) Applications for Medical Device:
System,Test,Thyroglobulin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K220972 | Beckman Coulter, Inc |
1000 Lake Hazeltine Dr | Chaska | MN | 55318 |
| K240927 | Beckman Coulter, Inc |
1000 Lake Hazeltine Dr | Chaska | MN | 55318 |
| K241423 | Beckman Coulter, Inc |
1000 Lake Hazeltine Dr | Chaska | MN | 55318 |
| K002905 | BECKMAN COULTER, INC. |
7330 CARROLL RD. | SAN DIEGO | CA | 92196 |
| K031269 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K021057 | BRAHMS DIAGNOSTICA, LLC. |
35 B SOUTH PEACHTREE ST. | NORCROSS | GA | 30071 |
| K982468 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K982466 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K002888 | NICHOLS INSTITUTE DIAGNOSTICS |
33047 CALLE AVIADOR | SAN JUAN CAPISTRANO | CA | 92675 |
| K994140 | NICHOLS INSTITUTE DIAGNOSTICS |
33051 CALLE AVIADOR | SAN JUAN CAPISTRANO | CA | 92675 |
| K221890 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 42650 |
| K242981 | Siemens Healthcare Diagnostics, Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K991720 | UNCHANGED |
1000 CALLE AMANECER | SAN CLEMENTE | CA | 92673 |
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