FDA 510(k) Applications for Medical Device:
Immunohistochemistry Antibody Assay, Estrogen Receptor
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013148 | BIOGENEX LABORATORIES |
4600 NORRIS CANYON RD. | SAN RAMON | CA | 94583 |
| K012138 | CHROMAVISION MEDICAL SYSTEMS, INC. |
33171 PASEO CERVEZA | SAN JUAN CAPESTRANO | CA | 92675 |
| K993957 | DAKO CORP. |
6392 VIA REAL | CARPINTERIA | CA | 93013 |
| K170028 | DAKO DENMARK A/S |
PRODUKTIONSVEJ 42 | GLOSTRUP | 2600 | |
| K081286 | DAKO NORTH AMERICA, INC. |
6392 VIA REAL | CARPINTERIA | CA | 93013 |
| K120663 | DAKO NORTH AMERICA, INC. |
6392 VIA REAL | CARPINTERIA | CA | 93013 |
| K061360 | LAB VISION CORP. |
47777 WARM SPRINGS BLVD. | FREMONT | CA | 94539 |
| K183100 | Leica Biosystems Newcastle Limited |
Balliol Business Park West, Benton Lane | Newcastle Upon Tyne | NE12 8EW | |
| K122556 | LEICA BIOSYSTEMS NEWCASTLE LTD |
5205 Route 12 | Richmond | IL | 60071 |
| K110215 | VENTANA MEDICAL SYSTEMS, INC. |
1910 EAST INNOVATION PARK DR. | TUCSON | AZ | 85755 |
| K984567 | VENTANA, INC. |
3865 NORTH BUSINESS CENTER | TUCSON | AZ | 85705 |
| K060227 | VISION BIOSYSTEMS INC. |
700 LONGWATER DRIVE | NORWELL | MA | 02061 |
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