FDA 510(k) Application Details - K112015

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K112015
Device Name	Assay, Glycosylated Hemoglobin
Applicant	PRIMUS CORPORATION DBA TRINITY BIOTECH 4231 E. 75TH TERRACE KANSAS CITY, MO 64132 US Other 510(k) Applications for this Company
Contact	BRITT EINSPAHR 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	07/13/2011
Decision Date	11/22/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review