FDA 510(k) Applications for Medical Device:
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K031857 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K964766 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K050596 | BIOKIT S.A. |
LLISSA D'AMUNT | BARCELONA | 08186 | |
| K972640 | BOEHRINGER MANNHEIM CORP. |
2380A BISSO LN. | CONCORD | CA | 94520 |
| K965100 | CRESTAT DIAGNOSTICS, INC. |
374 GOODHILL RD. | WESTON | CT | 06883 |
| K063610 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K053072 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K993444 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K052819 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K010978 | ROCHDIAG |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K123256 | THE BINDING SITE GROUP, LTD. |
8 CALTHORPE ROAD | BIRMINGHAM, WEST MIDLANDS | B15 1QT | |
| K011663 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K973391 | VENTANA MEDICAL SYSTEMS, INC. |
3865 N. BUSINESS CENTER DR. | TUCSON | AZ | 85705 |
| K973390 | VENTANA MEDICAL SYSTEMS, INC. |
3865 N. BUSINESS CENTER DR. | TUCSON | AZ | 85705 |
| K973392 | VENTANA MEDICAL SYSTEMS, INC. |
3865 N. BUSINESS CENTER DR. | TUCSON | AZ | 85705 |
| K973389 | VENTANA MEDICAL SYSTEMS, INC. |
3865 N. BUSINESS CENTER DR. | TUCSON | AZ | 85705 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
