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FDA 510(k) Application Details - K093243
Device Classification Name
Test, Time, Prothrombin
More FDA Info for this Device
510(K) Number
K093243
Device Name
Test, Time, Prothrombin
Applicant
COAGUSENSE, INC
42840 CHRISTY ST SUITE 110
FREMONT, CA 94538 US
Other 510(k) Applications for this Company
Contact
DOUGLAS PATERSON
Other 510(k) Applications for this Contact
Regulation Number
864.7750
More FDA Info for this Regulation Number
Classification Product Code
GJS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/15/2009
Decision Date
04/07/2010
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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