FDA 510(k) Applications for Medical Device:
Urinary Homocystine (Nonquantitative) Test System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K992858 | ABBOTT LABORATORIES |
DEPT 9YC, BIDG. AP31 | ABBOTT PARK | IL | 60064-6200 |
| K030754 | ANTICANCER INC |
7917 OSTROW ST. | SAN DIEGO | CA | 92111 |
| K080851 | ANTICANCER INC |
7917 OSTROW ST. | SAN DIEGO | CA | 92111 |
| K980907 | AXIS BIOCHEMICALS, ASA |
PO BOX 262069 | SAN DIEGO | CA | 92196 |
| K992274 | AXIS BIOCHEMICALS, ASA |
PO BOX 262069 | SAN DIEGO | CA | 92196 |
| K073640 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K112790 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, | DD2 1XA | |
| K083222 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K013606 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K013406 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K993107 | BIO-RAD |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547-1803 |
| K062808 | CATCH INCORPORATED |
21031 SE 202ND STREET | RENTON | WA | 98058 |
| K011689 | CATCH, INC. |
PO BOX 2219 | LONGVIEW | WA | 98632 |
| K063206 | DADE BEHRING, INC. |
GLASGOW SITE | NEWARK | DE | 19714-6101 |
| K052788 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K003597 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K071971 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K061296 | DIAZYME LABORATORIES |
3550 GENERAL ATOMICS CT. | SAN DIEGO | CA | 92121 |
| K121053 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K032012 | DIAZYME LABORATORIES |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K982003 | DREW SCIENTIFIC LTD. |
PARK RD.,TELEMETER BLDG. | BARROW IN FURNESS | LA 14 4QR | |
| K061598 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K011692 | INTERSECT SYSTEMS, INC. |
P.O. BOX 2219 | LONGVIEW | WA | 98632 |
| K123930 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K061588 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K033706 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K113793 | ROCHE |
9115 HAGUE RD | INDIANAPOLIS | IN | 46250 |
| K063701 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K121533 | Tosoh BioScience, Inc. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
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