FDA 510(k) Applications for Medical Device:
Albumin, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K142346 | Beckman Coulter Ireland Inc. |
Lismeehan, O'Callaghan's Mills | Co. Clare | ||
| K082251 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821 |
| K964695 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821-6208 |
| K972929 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K033525 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K061990 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K051191 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K091486 | KAMIYA BIOMEDICAL CO. |
12779 GATEWAY DR. | SEATTLE | WA | 98168 |
| K101089 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K042643 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K053553 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K961824 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K101203 | Roche Diagnostics |
9115 HAGUE RD | INDIANAPOLIS | IN | 46250 |
| K100853 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K113072 | ROCHE DIAGNOSTICS OPERATIONS |
9115 Hague Rd | Indianapolis | IN | 46256 |
| K143118 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD, | BIRMINGHAM | B15 1QT | |
| K153560 | THE BINDING SITE GROUP LTD |
8 CALTHORPE ROAD, | BIRMINGHAM | B15 1QT | |
| K121045 | THE BINDING SITE GROUP, LTD. |
8 CALTHORPE ROAD | EDGBASTON | B15 1QT |
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