FDA 510(k) Applications for Medical Device:
System, Multipurpose For In Vitro Coagulation Studies
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K202101 | Accriva Diagnostics, Inc. |
6260 Sequence Drive | San Diego | CA | 92121 |
| K193041 | Accriva Diagnostics, Inc. |
6260 Sequence Drive | San Diego | CA | 92121 |
| K983460 | AMERICAN BIOPRODUCTS CO. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K980839 | AVOCET MEDICAL, INC. |
1696 DELL AVE. | CAMPBELL | CA | 95008 |
| K970431 | BEHRING DIAGNOSTICS, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K051030 | BIOMERIEUX, INC. |
100 RODOLPHE ST | DURHAM | NC | 27712 |
| K050513 | BIOMERIEUX, INC. |
100 RODOLPHE ST | DURHAM | NC | 27712 |
| K974569 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K990566 | CARDIOVASCULAR DIAGNOSTICS, INC. |
5301 DEPARTURE DR. | RALEIGH | NC | 27616 |
| K150041 | Coramed Technologies, LLC |
6225 W. Howard St. | Niles | IL | 60714 |
| K013114 | DADE BEHRING, INC. |
GLASGOW SITE | NEWARK | DE | 19714-6101 |
| K011665 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK, | DE | 19714 |
| K000973 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K992959 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K002080 | DADE BEHRING, INC. |
7739 NW 48 ST. | MIAMI | FL | 33166 |
| K001064 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K984501 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K001067 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K023141 | DADE BEHRING, INC. |
514 GBC DR. | NEWARK | DE | 19702 |
| K011235 | DADE BEHRING, INC. |
13251 NW 9TH TERRACE | MIAMI | FL | 33182 |
| K981711 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K010494 | DADE BEHRING, INC. |
P.O. BOX | NEWARK | DE | 19714-6101 |
| K183390 | Diagnostic Grifols, S.A. |
Passeig Fluvial, 24 | Parets del Valles | 08150 | |
| K151867 | DIAGNOSTICA STAGO S.A.S. |
125 AVENUE LOUIS ROCHE | GENNEVILLIERS | 92230 | |
| K212183 | Diagnostica Stago SAS |
3 allΘe ThΘrΘsa | AsniΘres sur Seine | 92600 | |
| K093167 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K082248 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K082675 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K130090 | DIAGNOSTICA STAGO, INCORPORATED |
PIAZZA ALBANIA, 10 | ROME | 00153 | |
| K093001 | DIAGNOSTICA STAGO, INCORPORATED |
5 CENTURY DRIVE | PARSIPPPANY | NJ | 07054 |
| K050243 | FARALLON MEDIAL INC |
3521 INVESTEMENT BLVD | HAYWARD | CA | 94545 |
| K160502 | Haemonetics Corporation |
400 Wood Road | Braintree | MA | 02184 |
| K183160 | Haemonetics Corporation |
400 Wood Road | Braintree | MA | 02184 |
| K993678 | HAEMOSCOPE CORP. |
7855 GROSS POINT RD. | SKOKIE | IL | 60077 |
| K002177 | HAEMOSCOPE CORP. |
7855 GROSS POINT RD. | SKOKIE | IL | 60077 |
| K061014 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704-0752 |
| K050053 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K961908 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K000053 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K170314 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K083518 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K060162 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K221359 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K040359 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K002400 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K990449 | INTERNATIONAL TECHNIDYNE CORP. |
6 OLSEN AVE. | EDISON | NJ | 08820 |
| K974799 | INTERNATIONAL TECHNIDYNE CORP. |
23 NEVSKY ST. | EDISON | NJ | 08820 |
| K020798 | INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. | EDISON | NJ | 08820 |
| K030818 | INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. | EDISON | NJ | 08820 |
| K050016 | INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. | EDISON | NJ | 08820 |
| K071265 | INVERNESS MEDICAL INNOVATIONS, INC. |
51 SAWYER RD., SUITE 200 | WALTHAM | MA | 02453-3448 |
| K981815 | MEDTRONIC BLOOD MANAGEMENT |
18501 EAST PLAZA DR. | PARKER | CO | 80134-9061 |
| K954202 | MEDTRONIC HEMOTEC, INC. |
18501 EAST PLAZA DR. | PARKER | CO | 80134-9061 |
| K083842 | PENTAPHARM GMBH |
STAHLGRUBERRING 12 | MUNICH | D-81829 | |
| K994349 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K983892 | ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46256 |
| K173202 | Sekisui Medical Co., Ltd. |
1-3 Nihonbashi 2-Chome | Chuo-Ku | 103-00227 | |
| K172286 | Siemens Healthcare Diagnostic Products Gmbh |
Emil-von Behring Strasse 76 | Marburg | 35041 | |
| K150678 | Siemens Healthcare Diagnostic Products Gmbh |
EMIL-VON-BEHRING-STR. 76 | MARBURG | 35041 | |
| K083159 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K083175 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K151259 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
EMIL-VON BEHRING-STR. 76 | MARBURG | 35041 | |
| K161312 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
EMIL-VON-BEHRING-STR. 76 | MARBURG | 35041 | |
| K162420 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
EMIL-VON-BEHRING STRASSE 76 | Marburg | 35041 | |
| K161317 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring-Str. 76 | Marburg | 35041 | |
| K162688 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring Strasse 76 | Marburg | 35041 | |
| K172333 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring Strasse 76 | Marburg | 35041 | |
| K955720 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K021162 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K972260 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST.LOUIS | MO | 63103 |
| K955724 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K960875 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K955735 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K964946 | SYSMEX CORP. |
GILMER RD. | LONG GROVE | IL | 60047-9596 |
| K101533 | Tem Innovations GmbH |
MARTIN-KOLLAR STR 13-15 | MUNICH, BAVARIA/UPPER BAVARIA | 81829 | |
| K201440 | Tem Innovations GmbH |
Martin-Kollar-Strasse 15 | Munich | 81829 | |
| K083896 | TRINITY BIOTECH |
2823 GIRTS ROAD | JAMESTOWN | NY | 14701 |
| K033137 | WADA, INC. |
35949 NICOLET CT. | FREMONT | CA | 94536 |
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