FDA 510(k) Applications for Medical Device:
Igg, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983221 | ABBOTT LABORATORIES |
1921 HURD DR. | IRVING | TX | 75038 |
| K963974 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K963868 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K965108 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K010617 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K962202 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K993281 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K955798 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K040434 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K050113 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K993928 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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