FDA 510(k) Application Details - K132338

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K132338
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	DELBIO INCORPORATION 3F,6F, 7F No.252, Shangying Road, Guishan Industrial Zone Taoyuan County 33341 TW Other 510(k) Applications for this Company
Contact	ERICA LI 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	07/26/2013
Decision Date	10/24/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
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