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FDA 510(k) Application Details - K103544
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K103544
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
AGAMATRIX INC
7C RAYMOND AVE
SALEM, NH 03079 US
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Contact
WILLIAM H MCGRAIL
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
12/02/2010
Decision Date
12/07/2011
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
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