FDA 510(k) Application Details - K121842

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K121842
Device Name	Assay, Glycosylated Hemoglobin
Applicant	AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND DD2 1XA GB Other 510(k) Applications for this Company
Contact	CLAIRE I DORA 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	06/25/2012
Decision Date	12/12/2012
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