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FDA 510(k) Application Details - K161817
Device Classification Name
Test, Cystatin C
More FDA Info for this Device
510(K) Number
K161817
Device Name
Test, Cystatin C
Applicant
Roche Diagnostics Operations (RDO)
9115 Hague Road
Indianapolis, IN 46250 US
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Contact
Patrick Stimart
Other 510(k) Applications for this Contact
Regulation Number
862.1225
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Classification Product Code
NDY
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More FDA Info for this Product Code
Date Received
07/01/2016
Decision Date
07/27/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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