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 Other 510(k) Applications for this Company
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