FDA 510(k) Application Details - K180356

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K180356
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	Scanadu, Inc. 1196 Borregas Ave., Ste 200 Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	Daya Ranamukhaarachchi Other 510(k) Applications for this Contact
Regulation Number	862.1340   More FDA Info for this Regulation Number
Classification Product Code	JIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2018
Decision Date	05/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review