FDA 510(k) Applications for Medical Device:
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K071002 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92822-8000 |
| K070626 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821 |
| K053109 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | NEWARK | DE | 19714-6101 |
| K061802 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K033908 | DADE BEHRING, INC. |
GLASGOW SITE | NEWARK | DE | 19714-6101 |
| K060369 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K062924 | DADE BEHRING, INC. |
P.O. BOX 6101 BLDG 500;M.S.514 | NEWARK | DE | 19714-6101 |
| K063057 | DIAGNOSTIC PRODUCTS CORPORATION |
5210 PACIFIC CONCOURSE DR | LOS ANGELES | CA | 90045-6900 |
| K041668 | OLYMPUS AMERICA INC. |
3131 W. ROYAL LANE | IRVING | TX | 75063-3104 |
| K051564 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K041799 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K053603 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K042485 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K173833 | SENTINEL CH. SpA |
Via Robert Koch 2 | Milano | 20152 | |
| K081294 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K233242 | Siemens HealthCare Diagnostics Inc. |
500 GBC Drive | Newark | DE | 19714 |
| K212559 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring Str. 76 | Marburg | 35041 | |
| K071017 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
5210 PACIFIC CONCOURSE DR. | LOS ANGELES | CA | 90045-6900 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
