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FDA 510(k) Application Details - K063647
Device Classification Name
Test, Cystatin C
More FDA Info for this Device
510(K) Number
K063647
Device Name
Test, Cystatin C
Applicant
THERMO ELECTRON OY
RATASTIE 2
PO BOX 100
VANTAA FIN-01621 FI
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Contact
PAIVI SORMUNEN
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
12/07/2006
Decision Date
03/12/2007
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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