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FDA 510(k) Application Details - K093137
Device Classification Name
Test, Cystatin C
More FDA Info for this Device
510(K) Number
K093137
Device Name
Test, Cystatin C
Applicant
KAMIYA BIOMEDICAL CO.
12779 GATEWAY DR.
SEATTLE, WA 98168 US
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Contact
SHAWN KAPLAN
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
10/05/2009
Decision Date
09/28/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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