FDA 510(k) Application Details - K063209

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K063209
Device Name	Assay, Glycosylated Hemoglobin
Applicant	THERMO ELECTRON OY RATASTIE 2 VANTAA 01620 FI Other 510(k) Applications for this Company
Contact	PAIVI SORMUNEN Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2006
Decision Date	03/21/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review