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




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact