FDA 510(k) Applications for Medical Device:
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K974596 | AGEN BIOMEDICAL LTD. |
11DURBELL STREET, ACACIA | BRISBANE 4110 | ||
| K964718 | AMERICAN BIOPRODUCTS CO. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K964728 | AMERICAN BIOPRODUCTS CO. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K080069 | AMERICAN DIAGNOSTICA, INC. |
500 WEST AVENUE | STAMFORD | CT | 06902 |
| K973819 | BIOMERIEUX VITEK, INC. |
1022 HINGHAM ST. | ROCKLAND | MA | 02370 |
| K040882 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K112818 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K020810 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K030328 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K002642 | BIOPOOL INTL., INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K040437 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K042723 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K992957 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K041438 | DADE BEHRING, INC. |
BLDG. 500 MAIL BOX 514 | NEWARK | DE | 19714-6101 |
| K063356 | DADE BEHRING, INC. |
P.O. BOX 6101 BLDG 500;M.S.514 | NEWARK | DE | 19714-6101 |
| K051597 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K022976 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K022977 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K141144 | DIAGNOSTICA STAGO |
PIAZZA ALBANIA 10 | ITALAY | 00153 | |
| K162227 | Diagnostica Stago |
3, Allee Theresa | Asnieres sur Seine | 92600 | |
| K073042 | INSTRUMENTATION LABORATORY |
113 HARTWELL AVE. | LEXINGTON | MA | 02421 |
| K050278 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K050544 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K070927 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K151534 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL Road | BEDFORD | MA | 01730 |
| K160885 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K172903 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730-4207 |
| K090264 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K972696 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K032419 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K002948 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K030687 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K000492 | ORGANON TEKNIKA CORP. |
100 AKZO AVE. | DURHAM | NC | 27712 |
| K974776 | ORGANON TEKNIKA CORP. |
100 AKZO AVE. | DURHAM | NC | 27712 |
| K033491 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46256 |
| K002706 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K081732 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE M/S 514 | NEWARK | DE | 19702 |
| K093626 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K091916 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19714-6101 |
| K110303 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K013549 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K013544 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K013545 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K003267 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K012755 | XTRANA, INC. |
6025 NICOLLE ST. | VENTURA | CA |
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