FDA 510(k) Applications for Medical Device:
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K020806 | BAYER CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K972462 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K020807 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K981354 | BECKMAN INSTRUMENTS, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K080017 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K973351 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K071597 | DADE BEHRING, INC. |
P.O. BOX 6101 BLDG 500;M.S.514 | NEWARK | DE | 19714-6101 |
| K983263 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K990138 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. | WEBSTER | TX | 77598 |
| K081709 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
LISMEEHAN | O'CALLAGHANS MILLS, CO. CLARE | ||
| K213626 | Ortho Clinical Diagnostics |
Felindre Meadows | Pencoed | CF35 5PZ | |
| K983031 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K220176 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K981282 | ROCHE DIAGNOSTICS GMBH |
4300 HACIENDA DR. | PLEASANTON | CA | 94566-0900 |
| K090236 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K023894 | TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., | SAN FRANCISCO | CA | 94080 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
