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FDA 510(k) Application Details - K120866
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K120866
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
DELBIO INCORPORATION
3F, NO. 252, SHANGYING ROAD
GUISHAN INDUSTRIAL ZONE
TAOYUAN COUNTY 33341 TW
Other 510(k) Applications for this Company
Contact
NICKY PAN
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
03/22/2012
Decision Date
12/11/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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