FDA 510(k) Application Details - K182298

Device Classification Name	System, Hemoglobin, Automated   More FDA Info for this Device
510(K) Number	K182298
Device Name	System, Hemoglobin, Automated
Applicant	Immunostics, Inc. 38 Industrial Way East, Suite1 Eatontown, NJ 07724 US Other 510(k) Applications for this Company
Contact	Junghee Kim Other 510(k) Applications for this Contact
Regulation Number	864.5620   More FDA Info for this Regulation Number
Classification Product Code	GKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2018
Decision Date	11/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review