FDA 510(k) Application Details - K143169

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K143169
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	ENTRA HEALTH SYSTEMS 3111 Camino Del Rio North Suite 101 San Diego, CA 92108 US Other 510(k) Applications for this Company
Contact	RICHARD STROBRIDGE Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2014
Decision Date	01/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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