FDA 510(k) Application Details - K231476

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K231476
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	Sinocare Inc. No.265 Guyuan Road, Hi-Tech Zone, Changsha, Hunan Province Changsha 410205 CN Other 510(k) Applications for this Company
Contact	Qian Zhou 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	05/22/2023
Decision Date	12/01/2023
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
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