FDA 510(k) Applications for Medical Device:
Enzymatic Method, Bilirubin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K063845 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K053090 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K152343 | RANDOX LABORATORIES LIMITED |
55 DIAMOND ROAD, CRUMLIN | COUNTY ANTRIM | BT29 4QY | |
| K152344 | RANDOX LABORATORIES LIMITED |
55 DIAMOND ROAD,ARDMORE | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K170065 | Siemens Healthcare Diagnostics, Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K050266 | STANBIO LABORATORY |
1261 NORTH MAIN ST. | BOERNE | TX | 78006 |
| K053132 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K970985 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K053131 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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