FDA 510(k) Application Details - K012525

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K012525
Device Name	Assay, Glycosylated Hemoglobin
Applicant	THERMO DMA, INC. 845 AVE. G EAST ARLINGTON, TX 76011 US Other 510(k) Applications for this Company
Contact	THOMAS DOLLAR 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	08/06/2001
Decision Date	10/04/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review