FDA 510(k) Applications for Medical Device:
Radioimmunoassay, Vancomycin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K955851 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K964587 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K013076 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K123947 | BIOKIT S.A. |
CAN MALE, S/N | LLISSA D'AMUNT, BARCELONA | 08186 | |
| K072036 | BIOKIT S.A. |
CAN MALE S/N | BARCELONA | 08186 | |
| K020692 | DADE BEHRING, INC. |
514 GBC DR. | NEWARK | DE | 19702 |
| K963267 | DADE INTL., INC. |
BUILDING 500, MAILBOX 514 | NEWARK | DE | 19714-6101 |
| K063045 | DIAGNOSTIC PRODUCTS CORP. |
5210 PACIFIC CONCOURCE DR. | LOS ANGELES | CA | 90045-6900 |
| K983280 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K032811 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K043386 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K060586 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K152245 | ROCHE DIAGNOSTICS OPERATIONS (RDO) |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K050419 | SERADYN INC. |
7998 GEORGETOWN RD. | INDIANAPOLIS | IN | 46268 |
| K222439 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K160202 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
500 GBC DRIVE, PO BOX 6101 | Newark | DE | 19711 |
| K955716 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
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