FDA 510(k) Application Details - K182046

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K182046
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	Tyson Bioresearch, Inc. 5F., No. 16, 18, 20, 22, Kedong 3rd Rd. Zhunan Township 35053 TW Other 510(k) Applications for this Company
Contact	Vance Chang 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	07/31/2018
Decision Date	11/30/2018
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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