FDA 510(k) Applications for Medical Device:
System, Automated Platelet Aggregation
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K141427 |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K013596 |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K992531 |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K012701 |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K011337 |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K042423 |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K051231 |
ACCUMETRICS, INC. |
3985 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K122162 |
AGGREDYNE, INC. |
11874 SOUTH EVELYN CIRCLE
| HOUSTON |
TX |
77071 |
K163274 |
Aggredyne, Inc. |
10530 Rockley Road, Suite 150
| Houston |
TX |
77099 |
K181777 |
Aggredyne, Inc. |
10530 Rockely Road, Suite 150
| Houston |
TX |
77099 |
K990398 |
ARRAY MEDICAL, INC. |
ONE HARVARD WAY, SUITE 5
| SOMERVILLE |
NJ |
08876 |
K954997 |
CENTOCOR, INC. |
200 GREAT VALLEY PKWY.
| MALVERN |
PA |
19355-1307 |
K161329 |
Chrono-log Corp. |
2 West Park Road
| Havertown |
PA |
19083 |
K962426 |
CHRONO-LOG CORP. |
2 WEST PARK RD.
| HAVERTOWN |
PA |
19083 |
K032951 |
CHRONO-LOG CORP. |
2 WEST PARK RD.
| HAVERTOWN |
PA |
19083 |
K050265 |
CHRONO-LOG CORP. |
2 WEST PARK RD.
| HAVERTOWN |
PA |
19083 |
K140893 |
CORAMED TECHNOLOGIES, LLC |
6225 W. HOWARD ST.
| NILES |
IL |
60714 |
K060489 |
DADE BEHRING, INC. |
BLDG. 500 MAIL BOX 514
| NEWARK |
DE |
19714-6101 |
K002885 |
DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY;
| P.O. BOX 6101, NEWARK |
DE |
19714-6101 |
K970505 |
DADE INTL., INC. |
2173 NW 99TH AVE.
| MIAMI |
FL |
33172 |
K191364 |
Fujimori Kogyo Co., Ltd. |
Shinjuku First West 1-23-7 Nishi-Shinjuku
| Shinjuku, Tokyo |
|
160-0023 |
K041502 |
HAEMOSCOPE CORP. |
5693 WEST HOWARD
| NILES |
IL |
60714 |
K012723 |
HELENA LABORATORIES |
1530 LINDBERGH DR.
| BEAUMONT |
TX |
77704 |
K023761 |
HELENA LABORATORIES |
1530 LINDBERGH DR.
| BEAUMONT |
TX |
77704 |
K103555 |
VERUM DIAGNOSTICA GMBH |
REICHENBACHSTRASSE 27
| MUNICH |
|
80469 |
|
|