FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Carbamazepine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K103627 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064 |
| K000903 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K964068 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K042808 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K963673 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K955644 | BECKMAN INSTRUMENTS, INC. |
200 S. KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K964765 | CHIRON DIAGNOSTICS CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052 |
| K962820 | DADE INTL., INC. |
BUILDING 500, MAILBOX 514 | NEWARK | DE | 19714-6101 |
| K000007 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K980283 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14650-0882 |
| K123518 | Microgenics Corporation |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K011648 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K031902 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K151578 | Roche Diagnostics Operations (RDO) |
9115 Hague Road | Indianapolis | IN | 46250 |
| K973535 | SCHIAPPARELLI BIOSYSTEMS, INC. |
368 PASSAIC AVE. | FAIRFIELD | NJ | 07004 |
| K993028 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K993987 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K010814 | SYVA CO., DADE BEHRING, INC. |
P.O. BOX 49013 | SAN JOSE | CA | 95135 |
| K063131 | THERMO ELECTRON OY |
RATASTIE 2 | VANTAA | FIN-01621 |
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