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FDA 510(k) Application Details - K080384
Device Classification Name
Test, Cystatin C
More FDA Info for this Device
510(K) Number
K080384
Device Name
Test, Cystatin C
Applicant
THE BINDING SITE, LTD.
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA, CA 90404 US
Other 510(k) Applications for this Company
Contact
JAY H GELLER
Other 510(k) Applications for this Contact
Regulation Number
862.1225
More FDA Info for this Regulation Number
Classification Product Code
NDY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2008
Decision Date
06/06/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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