FDA 510(k) Application Details - K180509

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K180509
Device Name	Assay, Glycosylated Hemoglobin
Applicant	EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben 30179 DE Other 510(k) Applications for this Company
Contact	Mick Fenton 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	02/27/2018
Decision Date	02/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review