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FDA 510(k) Application Details - K002885
Device Classification Name
System, Automated Platelet Aggregation
More FDA Info for this Device
510(K) Number
K002885
Device Name
System, Automated Platelet Aggregation
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
RADAMES RIESGO
Other 510(k) Applications for this Contact
Regulation Number
864.5700
More FDA Info for this Regulation Number
Classification Product Code
JOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2000
Decision Date
06/21/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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