FDA 510(k) Applications for Medical Device:
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964185 | ABBOTT DIAGNOSTICS |
200 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3537 |
| K964020 | ABBOTT LABORATORIES |
DEPT 49C, BLDG. AP31 | ABBOTT PARK | IL | 60064-3537 |
| K020828 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K964098 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K983715 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K022329 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K240479 | Beckman Coulter, Inc |
1000 Lake Hazeltine Drive | Chaska | MN | 55318 |
| K031297 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K023597 | BECKMAN COULTER, INC. |
7330 CARROLL RD. | SAN DIEGO | CA | 92121 |
| K080561 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K080469 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K972162 | BOEHRINGER MANNHEIM CORP. |
9112 HAGUE RD. | INDIANAPOLIS | IN | 46256 |
| K980240 | BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR. | PLEASANTON | CA | 94588-2722 |
| K983391 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K981297 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K142895 | FUJIREBIO DIAGNOSTICS, INC |
201 GREAT VALLEY PARKWAY | MALVERN | PA | 19355 |
| K042731 | FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PKWY. | MALVERN | PA | 19355-1307 |
| K221355 | Ortho Clinical Diagnostics |
Felindre Meadows | Bridgend | CF35 5PZ | |
| K983875 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K143534 | ROCHE PROFESSIONAL DIAGNOSTICS |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K100321 | SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K213510 | Siemens Healthcare Diagnostics Products Ltd |
Glyn Rhonwy, Llanberis | Llanberis | LL55 4EL | |
| K200199 | Siemens Healthcare Diagnostics, Inc. |
511 Benedict Ave. | Tarrytown | NY | 10591 |
| K072794 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
5210 PACIFIC CONCOURSE DR. | LOS ANGELES | CA | 90045-6900 |
| K990431 | TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., | SAN FRANCISCO | CA | 94080 |
| K023891 | TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., | SAN FRANCISCO | CA | 94080 |
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